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Digital Imaging and Communications in Medicine (DICOM) Supplement 50: Mammography Computer-Aided Detection SR SOP Class Status: Draft 19 – June 28, 2000 (Public Comment) DICOM Standards Committee 1300 N. 17 th Street Rosslyn, Virginia 22209 USA

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Digital Imaging and Communications in Medicine (DICOM)

Supplement 50: Mammography Computer-Aided Detection SR SOP Class

Status: Draft 19 – June 28, 2000 (Public Comment)

DICOM Standards Committee

1300 N. 17th Street

Rosslyn, Virginia 22209 USA

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Table of Contents

Table of Contents ........................................................................................................................................................ 2

Foreword 5

Scope and Field of Application.................................................................................................................................. 6

OPEN ISSUES ..................................................................................................................................................... 6

Part 3, Annex A Addendum ....................................................................................................................................... 8

A.X STRUCTURED REPORT DOCUMENT INFORMATION OBJECT DEFINITIONS........................... 8A.X.1 CAD SR Information Object Definition............................................................................................ 8

A.X.1.1 Mammography CAD SR Information Object Description .................................................. 8A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model .................................................. 8A.X.1.3 Mammography CAD SR IOD Module Table ....................................................................... 8

A.X.1.3.1 ......Mammography CAD SR IOD Content Constraints..................................... 9A.X.1.3.1.1.....Template Identification ........................................................................... 9A.X.1.3.1.2.....Value Type ............................................................................................... 9A.X.1.3.1.3.....Relationship Constraints ........................................................................ 9

Part 3, Annex X Addendum .....................................................................................................................................11

ANNEX X (INFORMATIVE)..............................................................................................................................11X.1 Mammography CAD SR Content Tree Structure ...........................................................................11X.2 Mammography CAD SR Observation Context Encoding..............................................................13X.3 Mammography CAD SR Examples...................................................................................................14Example 1: Calcification and Mass Detection with No Findings ........................................................14Example 2: Calcification and Mass Detection with Findings...............................................................15Example 3: Calcification and Mass Detection, Temporal Differencing with Findings .....................20

Part 4 Addendum.......................................................................................................................................................30

B.5 STANDARD SOP CLASSES ....................................................................................................................30B.5.1.5 Structured Reporting Storage SOP Classes.............................................................................30

I.4 MEDIA STANDARD STORAGE SOP CLASSES ...................................................................................30O.2.x Mammography CAD SR SOP Class .........................................................................................30

O.4.1.x Mammography CAD SR SOP Class ..................................................................................30O.4.2.x Mammography CAD SR SOP Class ..................................................................................31

Part 6 Addendum.......................................................................................................................................................32

ANNEX A (NORMATIVE): REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID) ................................32

Part 16 Addendum ....................................................................................................................................................33

ANNEX X: MAMMOGRAPHY CAD SR IOD TEMPLATES.........................................................................33TID nnn1 Mammography CAD SR IOD Document Root Template.................................................34

Content Item Descriptions ..................................................................................................................35TID nnn2 Mammography CAD SR IOD Overall Impression/Recommendation Template...........35

Content Item Descriptions ..................................................................................................................35TID nnn3 Mammography CAD SR IOD Impression/Recommendation Body Template ..............36

Content Item Descriptions ..................................................................................................................36TID nnn4 Mammography CAD SR IOD Individual Impression/Recommendation Template ......37

Content Item Descriptions ..................................................................................................................37TID nnn5 Mammography CAD SR IOD Composite Feature Template ..........................................38TID nnn6 Mammography CAD SR IOD Composite Feature Body Template ................................39

Content Item Descriptions ..................................................................................................................40TID nnn9 Mammography CAD SR IOD Single Image Finding Template.......................................41

Content Item Descriptions ..................................................................................................................42TID nnn10 Mammography CAD SR IOD Single Image Finding Generic Template .....................42

Content Item Descriptions ..................................................................................................................42TID nnn11 Mammography CAD SR IOD Single Image Finding Breast Composition Template.43

Content Item Descriptions ..................................................................................................................43

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TID nnn12 Mammography CAD SR IOD Single Image Finding Breast Geometry Template .....43Content Item Descriptions ..................................................................................................................43

TID nnn13.1 Mammography CAD SR IOD Single Image Finding Individual CalcificationTemplate 44TID nnn13.2 Mammography CAD SR IOD Single Image Finding Calcification Cluster Template44TID nnn14 Mammography CAD SR IOD Single Image Finding Density Template ......................45TID nnn15 Mammography CAD SR IOD Single Image Finding Nipple Template ........................45

Content Item Descriptions ..................................................................................................................45TID nnn16 Mammography CAD SR IOD Single Image Finding Non-Lesion Template ...............46TID nnn17 Mammography CAD SR IOD Single Image Finding Selected Region Template ......46TID nnn18 Mammography CAD SR IOD Single Image Finding Image Quality Template...........47

Content Item Descriptions ..................................................................................................................47TID nnn19.1 Mammography CAD SR IOD Detections Performed Template ................................48TID nnn19.2 Mammography CAD SR IOD Analyses Performed Template...................................48TID nnn20 Mammography CAD SR IOD Detection Performed Template .....................................48

Content Item Descriptions ..................................................................................................................49TID nnn21 Mammography CAD SR IOD Analysis Performed Template .......................................50

Content Item Descriptions ..................................................................................................................50TID nnn21.5 Mammography CAD SR IOD Algorithm Identification Template ..............................50TID nnn22 Mammography CAD SR IOD Image Library Entry Template .......................................51

Content Item Descriptions ..................................................................................................................51TID nnn23.1 Mammography CAD SR IOD Linear Measurement Template ..................................52

Content Item Descriptions ..................................................................................................................52TID nnn23.2 Mammography CAD SR IOD Area Measurement Template.....................................52

Content Item Descriptions ..................................................................................................................52TID nnn23.3 Mammography CAD SR IOD Volume Measurement Template................................53

Content Item Descriptions ..................................................................................................................53TID nnn25 Mammography CAD SR IOD Geometry Template.........................................................53

ANNEX Y: MAMMOGRAPHY CAD SR IOD ADOPTIVE TERMINOLOGY AND NOMENCLATURE 54BI-RADS Terminology and Nomenclature: .........................................................................................54MQCM 1999 Terminology and Nomenclature........................................................................................54MQSA Terminology and Nomenclature...................................................................................................54

ANNEX Z: MAMMOGRAPHY CAD SR IOD MICROGLOSSARY ............................................................55CONTEXT GROUP 99115 – Overall Breast Composition ...................................................................55CONTEXT GROUP 99117 – Change Since Last Mammogram or Prior Surgery............................55CONTEXT GROUP 99118 – Characteristics of Shape ........................................................................56CONTEXT GROUP 99119 – Characteristics of Margin .......................................................................56CONTEXT GROUP 99120 – Density Modifier .......................................................................................56CONTEXT GROUP 99121 – Calcification Types ..................................................................................56CONTEXT GROUP 99122 – Calcification Distribution Modifier..........................................................57CONTEXT GROUP 99126.1 – Single Image Finding...........................................................................57CONTEXT GROUP 99126.2 – Composite Feature ..............................................................................58CONTEXT GROUP 99131 – Clockface Location..................................................................................58CONTEXT GROUP 99132 – Quadrant Location...................................................................................59CONTEXT GROUP 99133 – Side............................................................................................................59CONTEXT GROUP 99134 – Depth .........................................................................................................59CONTEXT GROUP 99135 – Assessment ..............................................................................................59CONTEXT GROUP 99136 – Recommended Follow-up ......................................................................60CONTEXT GROUP 99143 – Pathology Codes .....................................................................................60CONTEXT GROUP xxxx1 – Intended Use of CAD Output..................................................................63CONTEXT GROUP xxxx2 – Composite Feature Relations.................................................................63CONTEXT GROUP xxxx3 – Scope of Feature......................................................................................64CONTEXT GROUP xxxx4 – Quantitative Temporal Difference Type................................................64CONTEXT GROUP xxxx4.1 – Qualitative Temporal Difference Type ...............................................64CONTEXT GROUP xxxx5 – Nipple Status.............................................................................................64CONTEXT GROUP xxxx6 – Non-Lesion Object Type .........................................................................65CONTEXT GROUP xxxx7 – Image Quality Finding..............................................................................65

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CONTEXT GROUP xxxx8 – Status of Results ......................................................................................67CONTEXT GROUP xxxx9 – Types of CAD Analysis Performed........................................................67CONTEXT GROUP xxx10 – Types of Image Quality Assessment ....................................................68CONTEXT GROUP xxx11 – Types of Quality Control Standard ........................................................68CONTEXT GROUP xxx12 – Units of Follow-up Interval ......................................................................68CONTEXT GROUP xxx13 – Units of Linear Measurement .................................................................68CONTEXT GROUP xxx14 – Units of Area Measurement....................................................................69CONTEXT GROUP xxx15 – Units of Volume Measurement...............................................................69CONTEXT GROUP xxx16 – Linear Measurements..............................................................................69CONTEXT GROUP xxx17 – Area Measurements ................................................................................70CONTEXT GROUP xxx18 – Volume Measurements ...........................................................................70CONTEXT GROUP xxx19 – Units of 1D, 2D and 3D Measurement..................................................70CONTEXT GROUP xxx20 – CAD Processing Summary.....................................................................70

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Foreword

This supplement to the DICOM standard introduces the DICOM format for the results of computer-aideddetection (CAD) of potential malignancies in mammograms. The supplement provides the means forencoding a CAD system’s mammographic analysis. This includes such basic information as:

• Lesion type, e.g., density, microcalcification cluster, architectural distortion• Bounding regions of lesions, as given by a rectangle, ellipse or polyline• Correlation between lesions detected in different views of a mammogram

The supplement also defines the DICOM format for advanced mammographic findings more commonlyassociated with computer-aided diagnosis (CADx). Examples of such findings include the morphology oflesions, descriptions of the breast architecture, image quality metrics and overall impressions of andrecommendations for the mammogram. The use of CADx information is optional, so makers of systemsthat produce only CAD results can still use the format described herein.

This draft Supplement to the DICOM Standard was developed according to DICOM CommitteeProcedures. The DICOM Standard is developed in liaison with other Standards Organizations includingHL7, CEN/TC 251 in Europe and MEDIS-DC, JAMI, and JIRA in Japan, with review by otherorganizations.

The DICOM Standard is structured as a multi-part document using the guidelines established in thefollowing document:

- ISO/IEC Directives, 1989 Part 3 - Drafting and Presentation of International Standards.

This document is a Supplement to the DICOM Standard. It is an extension to PS 3.3, PS 3.4 and 3.6 ofthe published DICOM Standard which consists of the following parts:

PS 3.1 - Introduction and OverviewPS 3.2 - ConformancePS 3.3 - Information Object DefinitionsPS 3.4 - Service Class SpecificationsPS 3.5 - Data Structures and EncodingPS 3.6 - Data DictionaryPS 3.7 - Message ExchangePS 3.8 - Network Communication Support for Message ExchangePS 3.9 - Point-to-Point Communication Support for Message ExchangePS 3.10 - Media Storage and File FormatPS 3.11 - Media Storage Application ProfilesPS 3.12 - Media Formats and Physical MediaPS 3.13 - Print Management - Point-to-point Communication SupportPS 3.14 - Grayscale Standard Display FunctionPS 3.15 - Security Profiles

These Parts are independent but related documents.

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Scope and Field of Application

This supplement to the DICOM standard only defines how the results of a computer’s mammographicanalysis (the CAD output) should be encoded. It does not define or describe inputs to the CAD systemother than use of CAD output (e.g. prior year’s report) as input to subsequent temporal analyses; nordoes it treat CAD output for studies other than mammograms. Note that the CAD input may becomprised of digitized or digitally acquired X-ray images, ultrasound or other germane mammographicimages. Some of the information described is beyond that which current CAD systems can produce.However, the DICOM committee includes it because it is expected to become relevant during the lifetimeof the supplement.

The CAD output is in the form of a DICOM Structured Report. The report can be used on its own, forexample for displaying the detected lesions on a monitor or printer. It can be used within a largerStructured Report document, e.g., as part of a comprehensive mammogram screening report. It can evenbe used as input to a CAD system, for example to provide information on CAD detections in prior years’mammograms. In all cases, the output is a Structured Report (SR), so readers should become familiarwith Comprehensive SR IOD and corresponding SOP class. In addition, provision has been made toallow description of the CAD output using BI-RADS terminology and nomenclature (see Annex Y, Z).International organizations are being encouraged to contribute additional terminology and nomenclature.

This document specifies the Mammography CAD SR IOD and the corresponding CAD Storage SOPclass. Since this supplement proposes changes to existing parts of DICOM, the reader should have aworking understanding of the Standard.

The Mammography CAD SR IOD object is designed to allow a sparsely populated content tree,depending on the capabilities of the CAD system producing this object. Since the content tree defined inthis document can incorporate many of the same impressions a human observer would make (at least fora period of time) it is not a requirement that CAD systems be able to fully encode all elements in thecontent tree templates. Instead, CAD systems may populate optional elements as they see fit, to meetthe requirements of the market; different CAD systems may populate the content tree differently.

The content tree sparseness does put more burden onto devices parsing and interpreting the contenttree. Interoperability needs may force parsers to handle a broad array of sparsely populated trees.

OPEN ISSUES

1. What will the Supplement 53 Revision 18 “Observation Context, Quoted-Document” (currently TID25) and “Quoted Document Root Context” (currently TID 59) and their subordinate templates finallylook like? Are these sufficient for our needs?

2. International language translation: The CAD SR templates must have the flexibility to allow alternatelanguage translations for Code Meaning. Determine how Supplement 53, Revision 18,TID 90“Language Translation of code meaning field” should be incorporated into this document, andwhether that is sufficient. Determine whether this affects the use of the CAD SR templates asEnumerated versus Defined.

3. Is “Rendering Intent” in conflict with the guideline that an SR SCP will faithfully render the fullmeaning of the document? See Supplement 23, Final Text, Part 4, Annex O.

4. How can a text-only Mammo report be generated from the same CAD SR that includes SCOORD ifthe SCOORD is in a “Required for Presentation” sub-tree?

5. Can a Mammography CAD SR SCP device, depending on its capability, opt (when available) torender certain locale information in textual form (e.g. “There is mass in the upper-outer quadrant” or“at the 11 o’clock position”) rather than “at location (569,2334)” when it is the most appropriate meansof rendering the SR document to the clinician?

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6. Review sections added to Part 4, Annex O, to explain the intended “Behavior of an SCU” and“Behavior of an SCP” for the Mammography CAD SR SOP Class. See also Supplement 23, FinalText, Annex O: Structured Reporting Storage SOP Classes.

7. All of the Concept Names and Context Groups defined in this Supplement must be assigned CodeValues. The ACR is evaluating potential options for the encoding of the BI-RADSTM terminology.

8. Is there additional information we need to include about BI-RADSTM? Such as its use as definedterms vs. enumerated values, and allowing extensions for international use?

9. Review ACR legal statements

10. In TID nnn19.1 and TID nnn19.2, the Value Type of “Successful Detections”, “Failed Detections”,“Successful Analyses” and “Failed Analyses” was changed from CONTAINER to TEXT with a NULLvalue in order to maintain the rule from the Comprehensive SR IOD that “Content Items with a ValueType of CONTAINER shall only be the target of relationshis other than CONTAINS, if this relationshipis conveyed by-reference”. See Supplement 23, Final Text, A.35.3.3.1.2.

11. If a content item has Required Type “U” and its target content item(s) have Required Type “M” thenthe target content item is only required if the source content item exists. The explanation of RequiredType in Supplement 53 should clarify this.

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Part 3, Annex A Addendum

Add the following to PS 3.3 Annex A

Update the Composite Module Table to include Mammography CAD SR IOD and Modules

IODsModules

MammographyCAD SR

Patient M

SpecimenIdentification

C

General Study M

Patient Study U

SR DocumentSeries

M

GeneralEquipment

M

SR DocumentGeneral

M

SR DocumentContent

M

SOP Common M

A.X STRUCTURED REPORT DOCUMENT INFORMATION OBJECT DEFINITIONS

A.X.1 CAD SR Information Object Definition

A.X.1.1 Mammography CAD SR Information Object Description

The Mammography CAD SR IOD is a constrained Comprehensive SR IOD. The content may includetextual and a variety of coded information, numeric measurement values, references to the SOPInstances and spatial regions of interest within such SOP Instances. Relationships by-reference areenabled between Content Items.

A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model

The E-R Model in Section A.1.2 of this Part applies to the Mammography CAD SR IOD. The Frame ofReference IE, and the IEs at the level of the Image IE in Section A.1.2 are not components of theMammography CAD SR IOD. Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD.

A.X.1.3 Mammography CAD SR IOD Module Table

Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD.

Table A.X.1-1MAMMOGRAPHY CAD SR IOD MODULES

IE Module Reference Usage

Patient Patient C.7.1.1 M

Specimen Identification C.7.1.2 C - Required if the Observation Subject is aSpecimen

Study General Study C.7.2.1 M

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Patient Study C.7.2.2 U

Series SR Document Series C.17.1 M

Equipment General Equipment C.7.5.1 M

Document SR Document General C.17.2 M

SR Document Content C.17.3 M

SOP Common C.12.1 M

A.X.1.3.1 Mammography CAD SR IOD Content Constraints

A.X.1.3.1.1 Template Identification

• The Mammography CAD SR Document Root content item shall be ETID nnn1.• When another document is quoted, the Document Root Node shall use TID 59, Quoted Document

Root Context, and its subordinate templates, as described in Supplement 53, DICOM Part 16:Templates and Context Groups, Revision 18 or later.

• When a content item sub-tree from a quoted document is included by-value, its observation contextshall be defined byTID 25, Quoted-Document Observation Context, and its subordinate templates, asdescribed in Supplement 53, DICOM Part 16:Templates and Context Groups, Revision 18 or later.

A.X.1.3.1.2 Value TypeNote: The Mammography CAD SR Document Root template and its subordinate templates make use of the

following subset of the Value Type (0040,A040) as defined for the Comprehensive SR IOD:

TEXTCODENUMDATETIMEUIDREFPNAMESCOORDCOMPOSITEIMAGECONTAINER

A.X.1.3.1.3 Relationship ConstraintsNote: Table A.X.1-2 specifies the subset of the relationship constraints defined for the Comprehensive SR

IOD.that are used by the Mammography CAD SR IOD.

Table A.X.1-2RELATIONSHIP CONTENT CONSTRAINTS FOR MAMMOGRAPHY CAD SR IOD

Source Value Type Relationship Type(Enumerated Values)

Target Value Type

CONTAINER CONTAINS CODE, NUM, SCOORD, IMAGE1,CONTAINER.

TEXT, CODE, NUM,CONTAINER

HAS OBS CONTEXT TEXT, CODE, NUM, DATE, TIME,UIDREF, PNAME

IMAGE HAS ACQ CONTEXT TEXT, CODE, DATE, TIME.

TEXT, CODE HAS PROPERTIES TEXT, CODE, NUM, DATE, IMAGE1,SCOORD.

CODE, NUM INFERRED FROM CODE, NUM, SCOORD.

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SCOORD SELECTED FROM IMAGE1

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Part 3, Annex X Addendum

Add the following to PS 3.3

ANNEX X (INFORMATIVE)

X.1 Mammography CAD SR Content Tree Structure

The Mammography CAD SR IOD is a constrained instance of the Comprehensive SR IOD. Thetemplates are defined in Part 16 Annex X.a. All relationships defined in the Mammography CAD SR IOD templates are by-value, unless otherwise

stated.b. Content items referenced from another SR object instance, such as a prior Mammography CAD SR,

are duplicated by-value in the new SR object instance, with appropriate quoted document observationcontext.

HAS PROPERTIES

CONTAINS

INFERRED FROM

⟨ ⟨ ⟨

Document Root(CONTAINER)

IndividualImpression/Recommendation

IndividualImpression/Recommendation

INFERRED FROM INFERRED FROM

⟨ ⟨ ⟨

⟨ ⟨ ⟨

Summary ofDetections

(CODE)

Image Library(CONTAINER)

CONTAINS

OverallImpression/Recommendation

Image Image

⟨ ⟨ ⟨

HASACQUISITIONCONTEXT

HASACQUISITIONCONTEXT

⟨ ⟨ ⟨

INFERRED FROM

⟨ ⟨ ⟨

Summary ofAnalyses(CODE)

INFERRED FROM

⟨ ⟨ ⟨

Figure x.x.x.1: Top Levels of Mammography CAD SR Content Tree

The Document Root, Image Library, Summaries of Detections and Analyses, and OverallImpression/Recommendation sub-trees together form the content tree of the Mammography CAD SRIOD.

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⟨ ⟨ ⟨

HAS PROPERTIES

Successful Detections(TEXT)

Successful Analyses(TEXT)

Failed Detections(TEXT)

Detection Performed Detection Performed

HAS PROPERTIES HAS PROPERTIES

HAS PROPERTIES

⟨ ⟨ ⟨

⟨ ⟨ ⟨⟨ ⟨ ⟨⟨ ⟨ ⟨ ⟨ ⟨ ⟨

Analysis Performed Analysis Performed

HAS PROPERTIES HAS PROPERTIES

⟨ ⟨ ⟨

⟨ ⟨ ⟨⟨ ⟨ ⟨⟨ ⟨ ⟨

HAS PROPERTIES

Detection Performed Detection Performed

HAS PROPERTIES HAS PROPERTIES

⟨ ⟨ ⟨

⟨ ⟨ ⟨

Failed Analyses(TEXT)

HAS PROPERTIES

INFERRED FROM

Summary of Detections(CODE)

Analysis Performed Analysis Performed

HAS PROPERTIES HAS PROPERTIES

⟨ ⟨ ⟨

⟨ ⟨ ⟨

Image Image Region

SELECTED FROM

⟨ ⟨ ⟨

⟨ ⟨ ⟨

Image Image Region

SELECTED FROM

⟨ ⟨ ⟨

⟨ ⟨ ⟨

Summary of Analyses(CODE)

INFERRED FROM

Figure x.x.x.2: Summary of Detections and Analyses Levels ofMammography CAD SR Content Tree

The Summary of Detections and Summary of Analyses sub-trees are used to identify the algorithms usedand the work done by the CAD device. These sub-trees illuminate why CAD processing may not produceresults (no findings), which occurs in three categories:

a. All algorithms succeededb. Some algorithms succeeded, some failed, but no findings resultedc. All algorithms failed

Note 1: If the tree contains no Individual Impression/Recommendation nodes and all attempted detections andanalyses succeeded then the CAD device made no findings.

Note 2: Detections and Analyses that are not attempted are not listed in the Summary of Detections andSummary of Analyses trees.

Note 3: If the code value of the Summary of Detections or Summary of Analyses codes in TID nnn1 is “NotAttempted” then no detail of which algorithms were not attempted is provided.

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DETECTIONS

HAS PROPERTIES

INFERRED FROM

⟨ ⟨ ⟨

IndividualImpression/Recommendation

INFERRED FROM

⟨ ⟨ ⟨

Composite Feature(Code)

Single Image Finding(Code = CALC

CLUSTER)

Single Image Finding(Code)

Composite Feature(Code)

INFERRED FROM INFERRED FROM

Single Image Finding(Code)

Single Image Finding(Code)

HAS PROPERTIES

⟨ ⟨ ⟨

HAS PROPERTIES

⟨ ⟨ ⟨

HAS PROPERTIES

⟨ ⟨ ⟨

Single Image Finding(Code = IND CALC)

Single Image Finding(Code = IND CALC)

⟨ ⟨ ⟨

INFERRED FROM

HAS PROPERTIES

⟨ ⟨ ⟨

HAS PROPERTIES

⟨ ⟨ ⟨

Single Image Finding(Code = DENSITY)

HAS PROPERTIES

⟨ ⟨ ⟨

ANALYSES

Figure x.x.x.3: Individual Impression/Recommendation Levels ofMammography CAD SR Content Tree

The shaded area in Figure x.x.x.3 demarcates information resulting from Detection, whereas theunshaded area is information resulting from Analysis. This distinction is used in determining whether toplace algorithm identification information in the Summary of Detections or Summary of Analyses sub-trees.

The clustering of calcifications within a single image is considered to be a Detection process which resultsin a Single Image Finding. The spatial correlation of a calcification cluster in two views, resulting in aComposite Feature, is considered Analysis. The clustering of calcifications in a single image is the onlycircumstance in which a Single Image Finding can result from the combination of other Single ImageFindings, which must be Individual Calcifications.

Once a Single Image Finding or Composite Feature has been instantiated, it may be referenced by anynumber of Composite Features higher in the tree.

X.2 Mammography CAD SR Observation Context Encoding

• Any content item in the Content tree that has been duplicated (i.e., quoted) from another SR objectinstance has a HAS OBS CONTEXT relationship to one or more content items that describe thecontext of the SR object instance from which it originated, as a quoted document. This mechanismmay be used to combine reports (e.g., CAD 1, CAD 2, Human).

• Content items do not overwrite the Initial Observation Context defined outside the SR DocumentContent tree by other modules in the SR IOD (e.g., Patient, General Equipment, SR DocumentGeneral modules).

• Context is not inherited in by reference relationships.

The Impression/Recommendation section of the SR Document Content tree of a Mammography CAD SRIOD may contain a mixture of current (direct) and prior (quoted) single image findings and compositefeatures. The content items from current and prior contexts are target content items that have a by-value

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INFERRED FROM relationship to a Composite Feature content item. Content items quoted from acontext other than the Initial Observation Context have a HAS OBS CONTEXT relationship to targetcontent items that describe the context of the quoted document.

In the following example, Composite Feature and Single Image Finding 1 are current, and Single ImageFinding 2 is quoted from a prior document.

X.3 Mammography CAD SR Examples

The following is a simple and non-comprehensive illustration of an encoding of the Mammography CADSR IOD for Mammography computer aided detection results.

Example 1: Calcification and Mass Detection with No Findings

A CAD device processes a typical screening mammography case, i.e., there are four films and no cancer.CAD runs both density and calcification detection successfully and finds nothing. The mammogramsresemble:

The content tree structure would resemble:

Node Code Meaning of Concept Name Code Meaning of Value TID

1 Mammography CAD SR 1

1.1 Image Library 1

INFERRED FROM

RCC LCC RM

LO LMLO

HAS PROPERTIES

HAS OBS CONTEXT

HAS PROPERTIES

Composite Feature(Code)

Single Image Finding 1(Code)

Single Image Finding 2(Code)

Quoted DocumentContext Info.

• • • • • •

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.1.1 Image Used As Evidence IMAGE 1 22

1.1.1.1 Image Laterality Right 22

1.1.1.2 Image View Code Sequence Cranio-caudal 22

1.1.2 Image Used As Evidence IMAGE 2 22

1.1.2.1 Image Laterality Left 22

1.1.2.2 Image View Code Sequence Cranio-caudal 22

1.1.3 Image Used As Evidence IMAGE 3 22

1.1.3.1 Image Laterality Right 22

1.1.3.2 Image View Code Sequence Medio-lateral oblique 22

1.1.4 Image Used As Evidence IMAGE 4 22

1.1.4.1 Image Laterality Left 22

1.1.4.2 Image View Code Sequence Medio-lateral oblique 22

1.2 Summary of Detections Succeeded 1

1.2.1 Successful Detections 19.1

1.2.1.1 Detection Performed Density 20

1.2.1.1.1 Algorithm ID “Density Detector” 21.5

1.2.1.1.2 Algorithm Version “V3.7” 21.5

1.2.1.1.3 Reference to node 1.1.1 20

1.2.1.1.4 Reference to node 1.1.2 20

1.2.1.1.5 Reference to node 1.1.3 20

1.2.1.1.6 Reference to node 1.1.4 20

1.2.1.2 Detection Performed Individual Calcification 20

1.2.1.2.1 Algorithm ID “Calc Detector” 21.5

1.2.1.2.2 Algorithm Version “V2.4” 21.5

1.2.1.2.3 Reference to node 1.1.1 20

1.2.1.2.4 Reference to node 1.1.2 20

1.2.1.2.5 Reference to node 1.1.3 20

1.2.1.2.6 Reference to node 1.1.4 20

1.3 Summary of Analyses Not Attempted 1

1.4 Overall Impression/Recommendation All algorithms succeeded;without findings

2

Example 2: Calcification and Mass Detection with Findings

A CAD device processes a screening mammography case with four films and a mass in the left breast.CAD runs both density and calcification detection successfully. It finds two densities in the LCC, onedensity in the LMLO, a cluster of three calcifications in the RCC and a cluster of 20 calcifications in the

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RMLO. It performs two clustering algorithms. One identifies individual calcifications and then clustersthem, and the second simply detects calcification clusters. It performs mass correlation and combinesone of the LCC densities and the LMLO density into a mass; the other LCC density is flagged Not forPresentation, therefore not intended for display to the end-user. The mammograms resemble:

RCC LCC RM

LO LMLO

The content tree structure would resemble (preliminary diagram):

IMAGELATERALITY

IMAGEREFERENCE

HAS PROP

IMAGE CODEVIEW

SEQUENCE

IMAGELATERALITY

IMAGEREFERENCE

HAS PROP

IMAGE CODEVIEW

SEQUENCE

IMAGELATERALITY

IMAGEREFERENCE

HAS PROP

IMAGE CODEVIEW

SEQUENCE

MammographyCAD SR

CONTAINER

CONTAINS

IMAGELIBRARY

CONTAINER

CONTAINS

IMAGELATERALITY

IMAGEREFERENCE

HAS PROP

IMAGE CODEVIEW

SEQUENCE

CONTAINS

SUMMARY OFANALYSES

CODE:SUCCEEDED

HAS PROP

DETECTIONPERFORMED

CODE:CALCIFICATION

CLUSTER

HAS PROP

ALGORITHM ID"CALC CLUSTER

DETECTOR"

ALGORITHMVERSION "V2.4"

INFER

CONTAINS

SUMMARY OFDETECTIONS

CODE:SUCCEEDED

CONTAINS

DETECTIONPERFORMED

CODE:CALCIFICATION

CLUSTER

HAS PROP

ALGORITHM ID"CALC CLUSTER

DETECTOR"

ALGORITHMVERSION "V2.4"

INFER

DETECTIONPERFORMED

CODE:CALCIFICATION

CLUSTER

HAS PROP

ALGORITHM ID"CALC CLUSTER

DETECTOR"

ALGORITHMVERSION "V2.4"

INFER

DETECTIONPERFORMED

CODE:CALCIFICATION

CLUSTER

HAS PROP

ALGORITHM ID"CALC CLUSTER

DETECTOR"

ALGORITHMVERSION "V2.4"

INFER

ANALYSISPERFORMEDCODE: MASS

CORRELATION

HAS PROP

ALGORITHM ID"MASS MAKER"

ALGORITHMVERSION "V1.9"

INFER

CONTAINS

OVERALLIMPRESSION/

RECOMMENDATION

HAS PROP

ANALYSISPERFORMEDCODE: MASS

CORRELATION

HAS PROP

ALGORITHM ID"MASS MAKER"

ALGORITHMVERSION "V1.9"

INFER

Node Code Meaning of Concept Name Code Meaning of Value TID

1 Mammography CAD SR 1

1.1 Image Library 1

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.1.1 Image Used As Evidence IMAGE 1 22

1.1.1.1 Image Laterality Right 22

1.1.1.2 Image View Code Sequence Cranio-caudal 22

1.1.1.3 Study Date 19990101 22

1.1.2 Image Used As Evidence IMAGE 2 22

1.1.2.1 Image Laterality Left 22

1.1.2.2 Image View Code Sequence Cranio-caudal 22

1.1.2.3 Study Date 19990101 22

1.1.3 Image Used As Evidence IMAGE 3 22

1.1.3.1 Image Laterality Right 22

1.1.3.2 Image View Code Sequence Medio-lateral oblique 22

1.1.3.3 Study Date 19990101 22

1.1.4 Image Used As Evidence IMAGE 4 22

1.1.4.1 Image Laterality Left 22

1.1.4.2 Image View Code Sequence Medio-lateral oblique 22

1.1.4.3 Study Date 19990101 22

1.2 Summary of Detections Succeeded 1

1.2.1 Successful Detections 19.1

1.2.1.1 Detection Performed Density 20

1.2.1.1.1 Algorithm ID “Density Detector” 21.5

1.2.1.1.2 Algorithm Version “V3.7” 21.5

1.2.1.1.3 Reference to node 1.1.1 20

1.2.1.1.4 Reference to node 1.1.2 20

1.2.1.1.5 Reference to node 1.1.3 20

1.2.1.1.6 Reference to node 1.1.4 20

1.2.1.2 Detection Performed Individual Calcification 20

1.2.1.2.1 Algorithm ID “Calc Detector” 21.5

1.2.1.2.2 Algorithm Version “V2.4” 21.5

1.2.1.2.3 Reference to node 1.1.1 20

1.2.1.2.4 Reference to node 1.1.2 20

1.2.1.2.5 Reference to node 1.1.3 20

1.2.1.2.6 Reference to node 1.1.4 20

1.2.1.3 Detection Performed Calcification Cluster 20

1.2.1.3.1 Algorithm ID “Calc Clustering” 21.5

1.2.1.3.2 Algorithm Version “V2.4” 21.5

1.2.1.3.3 Reference to node 1.1.1 20

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.2.1.4 Detection Performed Calcification Cluster 20

1.2.1.4.1 Algorithm ID “Calc Cluster Detector” 21.5

1.2.1.4.2 Algorithm Version “V2.4” 21.5

1.2.1.4.3 Reference to node 1.1.1 20

1.2.1.4.4 Reference to node 1.1.2 20

1.2.1.4.5 Reference to node 1.1.3 20

1.2.1.4.6 Reference to node 1.1.4 20

1.3 Summary of Analyses Succeeded 1

1.3.1 Successful Analyses 19.2

1.3.1.1 Analysis Performed Mass Correlation 21

1.3.1.1.1 Algorithm ID “Mass Maker” 21.5

1.3.1.1.2 Algorithm Version “V1.9” 21.5

1.3.1.1.3 Reference to node 1.1.2 21

1.3.1.1.4 Reference to node 1.1.4 21

1.4 Overall Impression/Recommendation All algorithms succeeded;with findings

2

1.4.1 Individual Impression/Recommendation INDIVIDUAL 4

1.4.1.1 Rendering Intent Presentation Required 4

1.4.1.2 Composite Feature Mass 5

1.4.1.2.1 Composite type Target content items arerelated spatially

6

1.4.1.2.2 Scope of Feature Feature was detected onmultiple images

6

1.4.1.2.3 Rendering Intent Presentation Required 6

1.4.1.2.4 Single Image Finding Density 9

1.4.1.2.4.1 Rendering Intent Presentation Required 9

1.4.1.2.4.2 Center POINT 25

1.4.1.2.4.2.1 Reference to node 1.1.2 25

1.4.1.2.4.3 Outline SCOORD 25

1.4.1.2.4.3.1 Reference to node 1.1.2 25

1.4.1.2.5 Single Image Finding Density 9

1.4.1.2.5.1 Rendering Intent Presentation Required 9

1.4.1.2.5.2 Area Measurement Area of Defined Region 14

1.4.1.2.5.2.1 Measurement Name Area of density 23.2

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.1.2.5.2.2 Area 2 cm2 23.2

1.4.1.2.5.2.3 Area Outline SCOORD 23.2

1.4.1.2.5.2.3.1 Reference to node 1.1.4 23.2

1.4.1.2.5.3 Center POINT 25

1.4.1.2.5.3.1 Reference to node 1.1.4 25

1.4.1.2.5.4 Outline SCOORD 25

1.4.1.2.5.4.1 Reference to node 1.1.4 25

1.4.2 Individual Impression/Recommendation INDIVIDUAL 4

1.4.2.1 Rendering Intent Not for Presentation 4

1.4.2.2 Single Image Finding Density 9

1.4.2.2.1 Rendering Intent Not for Presentation 9

1.4.2.2.2 Center POINT 25

1.4.2.2.2.1 Reference to node 1.1.2 25

1.4.2.2.3 Outline SCOORD 25

1.4.2.2.3.1 Reference to node 1.1.2 25

1.4.3 Individual Impression/Recommendation INDIVIDUAL 4

1.4.3.1 Rendering Intent Presentation Required 4

1.4.3.2 Single Image Finding Calcification Cluster 9

1.4.3.2.1 Rendering Intent Presentation Required 9

1.4.3.2.2 Number of Calcifications 20 13.2

1.4.3.2.3 Center POINT 25

1.4.3.2.3.1 Reference to node 1.1.3 25

1.4.3.2.4 Outline SCOORD 25

1.4.3.2.4.1 Reference to node 1.1.3 25

1.4.4 Individual Impression/Recommendation INDIVIDUAL 4

1.4.4.1 Rendering Intent Presentation Required 4

1.4.4.2 Single Image Finding Calcification Cluster 9

1.4.4.2.1 Rendering Intent Presentation Required 9

1.4.4.2.2 Number of Calcifications 3 13.2

1.4.4.2.3 Center POINT 25

1.4.4.2.3.1 Reference to node 1.1.1 25

1.4.4.2.4 Outline SCOORD 25

1.4.4.2.4.1 Reference to node 1.1.1 25

1.4.4.2.5 Single Image Finding Individual Calcification 9

1.4.4.2.5.1 Rendering Intent Presentation Optional 9

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.4.2.5.2 Center POINT 25

1.4.4.2.5.2.1 Reference to node 1.1.1 25

1.4.4.2.5.3 Outline SCOORD 25

1.4.4.2.5.3.1 Reference to node 1.1.1 25

1.4.4.2.6 Single Image Finding Individual Calcification 9

1.4.4.2.6.1 Rendering Intent Presentation Optional 9

1.4.4.2.6.2 Center POINT 25

1.4.4.2.6.2.1 Reference to node 1.1.1 25

1.4.4.2.6.3 Outline SCOORD 25

1.4.4.2.6.3.1 Reference to node 1.1.1 25

1.4.4.2.7 Single Image Finding Individual Calcification 9

1.4.4.2.7.1 Rendering Intent Presentation Optional 9

1.4.4.2.7.2 Center POINT 25

1.4.4.2.7.2.1 Reference to node 1.1.1 25

1.4.4.2.7.3 Outline SCOORD 25

1.4.4.2.7.3.1 Reference to node 1.1.1 25

Example 3: Calcification and Mass Detection, Temporal Differencing with Findings

The patient in Example 2 returns for another mammogram. A more comprehensive CAD (CADx) deviceprocesses the current mammogram. The prior CAD report (from Example 2) is referenced and sectionsof the content tree from the prior CAD report are incorporated. In the current mammogram the number ofcalcifications in the RCC has increased, and the size of the mass in the left breast has increased from 2to 4 cm2.

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RCC LCC RM

LO LMLO

RCC LCC RM

LO LMLO

Prior

Current

Bolded entries (xxx) in the following table denote references to or by-value inclusion of quoted contenttree items from a prior Mammography CAD SR instance (see example 2).

Node Code Meaning of Concept Name Code Meaning of Value TID

1 Mammography CAD SR 1

1.x Observation Context of Quoted DocumentRoot

59§531

1.1 Image Library 1

1.1.1 Image Used As Evidence IMAGE 1 22

1.1.1.1 Image Laterality Right 22

1.1.1.2 Image View Code Sequence Cranio-caudal 22

1.1.1.3 Study Date 20000101 22

1.1.2 Image Used As Evidence IMAGE 2 22

1.1.2.1 Image Laterality Left 22

1.1.2.2 Image View Code Sequence Cranio-caudal 22

1.1.2.3 Study Date 20000101 22

1.1.3 Image Used As Evidence IMAGE 3 22

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.1.3.1 Image Laterality Right 22

1.1.3.2 Image View Code Sequence Medio-lateral oblique 22

1.1.3.3 Study Date 20000101 22

1.1.4 Image Used As Evidence IMAGE 4 22

1.1.4.1 Image Laterality Left 22

1.1.4.2 Image View Code Sequence Medio-lateral oblique 22

1.1.4.3 Study Date 20000101 22

1.1.5 Image Used As Evidence IMAGE 5 22

1.1.5.1 Image Laterality Right 22

1.1.5.2 Image View Code Sequence Cranio-caudal 22

1.1.5.3 Study Date 19990101 22

1.1.6 Image Used As Evidence IMAGE 6 22

1.1.6.1 Image Laterality Left 22

1.1.6.2 Image View Code Sequence Cranio-caudal 22

1.1.6.3 Study Date 19990101 22

1.1.7 Image Used As Evidence IMAGE 7 22

1.1.7.1 Image Laterality Right 22

1.1.7.2 Image View Code Sequence Medio-lateral oblique 22

1.1.7.3 Study Date 19990101 22

1.1.8 Image Used As Evidence IMAGE 8 22

1.1.8.1 Image Laterality Left 22

1.1.8.2 Image View Code Sequence Medio-lateral oblique 22

1.1.8.3 Study Date 19990101 22

1.2 Summary of Detections Succeeded 1

1.2.1 Successful Detections 19.1

1.2.1.1 Detection Performed Density 20

1.2.1.1.1 Algorithm ID “Density Detector” 21.5

1.2.1.1.2 Algorithm Version “V3.7” 21.5

1.2.1.1.3 Reference to node 1.1.1 20

1.2.1.1.4 Reference to node 1.1.2 20

1.2.1.1.5 Reference to node 1.1.3 20

1.2.1.1.6 Reference to node 1.1.4 20

1.2.1.2 Detection Performed Individual Calcification 20

1.2.1.2.1 Algorithm ID “Calc Detector” 21.5

1.2.1.2.2 Algorithm Version “V2.4” 21.5

1.2.1.2.3 Reference to node 1.1.1 20

1.2.1.2.4 Reference to node 1.1.2 20

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.2.1.2.5 Reference to node 1.1.3 20

1.2.1.2.6 Reference to node 1.1.4 20

1.2.1.3 Detection Performed Calcification Cluster 20

1.2.1.3.1 Algorithm ID “Calc Clustering” 21.5

1.2.1.3.2 Algorithm Version “V2.4” 21.5

1.2.1.3.3 Reference to node 1.1.1 20

1.2.1.4 Detection Performed Calcification Cluster 20

1.2.1.4.1 Algorithm ID “Calc Cluster Detector” 21.5

1.2.1.4.2 Algorithm Version “V2.4” 21.5

1.2.1.4.3 Reference to node 1.1.1 20

1.2.1.4.4 Reference to node 1.1.2 20

1.2.1.4.5 Reference to node 1.1.3 20

1.2.1.4.6 Reference to node 1.1.4 20

1.3 Summary of Analyses Succeeded 1

1.3.1 Successful Analyses 19.2

1.3.1.1 Analysis Performed Mass Correlation 21

1.3.1.1.1 Algorithm ID “Mass Maker” 21.5

1.3.1.1.2 Algorithm Version “V1.9” 21.5

1.3.1.1.3 Reference to node 1.1.2 21

1.3.1.1.4 Reference to node 1.1.4 21

1.4 Overall Impression/Recommendation All algorithms succeeded;with findings

2

1.4.1 Assessment Category 4 – Suspiciousabnormality, biopsyshould be considered

3

1.4.2 Recommend Follow-up Interval 0 days 3

1.4.3 Individual Impression/Recommendation INDIVIDUAL 4

1.4.3.1 Rendering Intent Presentation Required 4

1.4.3.2 Differential Diagnosis/Impression Increase in size 3

1.4.3.3 Impression description “Worrisome increase insize”

3

1.4.3.4 Certainty of impression 84% 3

1.4.3.5 Recommended Follow-up Needle localization andbiopsy (L)

3

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.3.6 Composite Feature Mass 5

1.4.3.6.1 Composite type Target content items arerelated temporally

6

1.4.3.6.2 Scope of Feature Feature was detected onmultiple images

6

1.4.3.6.3 Rendering Intent Presentation Required 6

1.4.3.6.4 Certainty of Feature 91% 6

1.4.3.6.5 Probability of Cancer 84% 6

1.4.3.6.6 Pathology Lobular carcinoma in situ 6

1.4.3.6.7 Quantitative Difference Size 6

1.4.3.6.7.1 Difference value A-B 2 cm2 6

1.4.3.6.7.2 Reference to node1.4.3.8.6.1.2

6

1.4.3.6.7.3 Reference to node1.4.3.7.5.2.2

6

1.4.3.6.8 Lesion Density High density 6

1.4.3.6.9 Shape Lobular 6

1.4.3.6.10 Margins Microlobulated 6

1.4.3.7 Composite Feature Mass 5

1.4.3.7.1 Composite type Target content items arerelated spatially

6

1.4.3.7.2 Scope of Feature Feature was detected onmultiple images

6

1.4.3.7.3 Rendering Intent Presentation Required 6

1.4.3.7.4 Single Image Finding Density 9

1.4.3.7.4.1 Rendering Intent Presentation Required 9

1.4.3.7.4.2 Center POINT 25

1.4.3.7.4.2.1 Reference to node 1.1.2 25

1.4.3.7.4.3 Outline SCOORD 25

1.4.3.7.4.3.1 Reference to node 1.1.2 25

1.4.3.7.5 Single Image Finding Density 9

1.4.3.7.5.1 Rendering Intent Presentation Required 9

1.4.3.7.5.2 Area Measurement Area of Defined Region 14

1.4.3.7.5.2.1 Measurement Name Area of density 23.2

1.4.3.7.5.2.2 Area 4 cm2 23.2

1.4.3.7.5.2.3 Area Outline SCOORD 23.2

1.4.3.7.5.2.3.1 Reference to node 1.1.4 23.2

1.4.3.7.5.3 Center POINT 25

1.4.3.7.5.3.1 Reference to node 1.1.4 25

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.3.7.5.4 Outline SCOORD 25

1.4.3.7.5.4.1 Reference to node 1.1.4 25

1.4.3.8 Composite Feature Mass 5

1.4.3.8.1 Composite type Target content items arerelated spatially

6

1.4.3.8.2 Scope of Feature Feature was detected onmultiple images

6

1.4.3.8.3 Rendering Intent Presentation Required 6

1.4.3.8.4 Observation Context of Quoted Document 25§531

1.4.3.8.5 Single Image Finding Density 9

1.4.3.8.5.1 Rendering Intent Presentation Required 9

1.4.3.8.5.2 Center POINT 25

1.4.3.8.5.2.1 Reference to node 1.1.6 25

1.4.3.8.5.3 Outline SCOORD 25

1.4.3.8.5.3.1 Reference to node 1.1.6 25

1.4.3.8.6 Single Image Finding Density 9

1.4.3.8.6.1 Rendering Intent Presentation Required 9

1.4.3.8.6.1 Area Measurement Area of Defined Region 14

1.4.3.8.6.1.1 Measurement Name Area of density 23.2

1.4.3.8.6.1.2 Area 2 cm2 23.2

1.4.3.8.6.1.3 Area Outline SCOORD 23.2

1.4.3.8.6.1.3.1 Reference to node 1.1.8 23.2

1.4.3.8.6.2 Center POINT 25

1.4.3.8.6.2.1 Reference to node 1.1.8 25

1.4.3.8.6.3 Outline SCOORD 25

1.4.3.8.6.3.1 Reference to node 1.1.8 25

1.4.4 Individual Impression/Recommendation INDIVIDUAL 4

1.4.4.1 Rendering Intent Not for Presentation 4

1.4.4.2 Single Image Finding Density 9

1.4.4.2.1 Rendering Intent Not for Presentation 9

1.4.4.2.2 Center POINT 25

1.4.4.2.2.1 Reference to node 1.1.2 25

1.4.4.2.3 Outline SCOORD 25

1.4.4.2.3.1 Reference to node 1.1.2 25

1.4.5 Individual Impression/Recommendation INDIVIDUAL 4

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.5.1 Rendering Intent Presentation Required 4

1.4.5.2 Single Image Finding Calcification Cluster 9

1.4.5.2.1 Rendering Intent Presentation Required 9

1.4.5.2.2 Number of Calcifications 20 13.2

1.4.5.2.3 Center POINT 25

1.4.5.2.3.1 Reference to node 1.1.3 25

1.4.5.2.4 Outline SCOORD 25

1.4.5.2.4.1 Reference to node 1.1.3 25

1.4.6 Individual Impression/Recommendation INDIVIDUAL 4

1.4.6.1 Rendering Intent Presentation Required 4

1.4.6.2 Differential Diagnosis/Impression Increase in number ofcalcifications

3

1.4.6.3 Impression description “Calcification cluster hasincreased in size”

3

1.4.6.4 Certainty of impression 100% 3

1.4.6.5 Recommended Follow-up Magnification views (M) 3

1.4.7.2 Composite Feature Calcification Cluster 5

1.4.7.2.1 Composite type Target content items arerelated temporally

6

1.4.7.2.2 Scope of Feature Feature was detected onmultiple images

6

1.4.7.2.3 Rendering Intent Presentation Required 6

1.4.7.2.4 Certainty of Feature 99% 6

1.4.7.2.5 Probability of Cancer 54% 6

1.4.7.2.6 Pathology Ductal carcinoma in situ 6

1.4.7.2.7 Quantitative Difference Number of Calcifications 6

1.4.7.2.7.1 Difference value A-B 3 6

1.4.7.2.7.2 Reference to node1.4.7.2.10.2

6

1.4.7.2.7.3 Reference to node1.4.7.2.11.2

6

1.4.7.2.8 Calcification type Fine, linear, branching(casting)

6

1.4.7.2.9 Calcification distribution Grouped or clustered 6

1.4.7.2.10 Single Image Finding Calcification Cluster 9

1.4.7.2.10.1 Rendering Intent Presentation Required 9

1.4.7.2.10.2 Number of Calcifications 6 13.2

1.4.7.2.10.3 Center POINT 25

1.4.7.2.10.3.1 Reference to node 1.1.1 25

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.7.2.10.4 Outline SCOORD 25

1.4.7.2.10.4.1 Reference to node 1.1.1 25

1.4.7.2.10.5 Single Image Finding Individual Calcification 9

1.4.7.2.10.5.1 Rendering Intent Presentation Optional 9

1.4.7.2.10.5.2 Center POINT 25

1.4.7.2.10.5.2.1 Reference to node 1.1.1 25

1.4.7.2.10.5.3 Outline SCOORD 25

1.4.7.2.10.5.3.1 Reference to node 1.1.1 25

1.4.7.2.10.6 Single Image Finding Individual Calcification 9

1.4.7.2.10.6.1 Rendering Intent Presentation Optional 9

1.4.7.2.10.6.2 Center POINT 25

1.4.7.2.10.6.2.1 Reference to node 1.1.1 25

1.4.7.2.10.6.3 Outline SCOORD 25

1.4.7.2.10.6.3.1 Reference to node 1.1.1 25

1.4.7.2.10.7 Single Image Finding Individual Calcification 9

1.4.7.2.10.7.1 Rendering Intent Presentation Optional 9

1.4.7.2.10.7.2 Center POINT 25

1.4.7.2.10.7.2.1 Reference to node 1.1.1 25

1.4.7.2.10.7.3 Outline SCOORD 25

1.4.7.2.10.7.3.1 Reference to node 1.1.1 25

1.4.7.2.10.8 Single Image Finding Individual Calcification 9

1.4.7.2.10.8.1 Rendering Intent Presentation Optional 9

1.4.7.2.10.8.2 Center POINT 25

1.4.7.2.10.8.2.1 Reference to node 1.1.1 25

1.4.7.2.10.8.3 Outline SCOORD 25

1.4.7.2.10.8.3.1 Reference to node 1.1.1 25

1.4.7.2.10.9 Single Image Finding Individual Calcification 9

1.4.7.2.10.9.1 Rendering Intent Presentation Optional 9

1.4.7.2.10.9.2 Center POINT 25

1.4.7.2.10.9.2.1 Reference to node 1.1.1 25

1.4.7.2.10.9.3 Outline SCOORD 25

1.4.7.2.10.9.3.1 Reference to node 1.1.1 25

1.4.7.2.10.10 Single Image Finding Individual Calcification 9

1.4.7.2.10.10.1 Rendering Intent Presentation Optional 9

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Node Code Meaning of Concept Name Code Meaning of Value TID

1.4.7.2.10.10.2 Center POINT 25

1.4.7.2.10.10.2.1 Reference to node 1.1.1 25

1.4.7.2.10.10.3 Outline SCOORD 25

1.4.7.2.10.10.3.1 Reference to node 1.1.1 25

1.4.7.2.11 Single Image Finding Calcification Cluster 9

1.4.7.2.11.1 Rendering Intent Presentation Required 9

1.4.7.2.11.2 Number of Calcifications 3 13.2

1.4.7.2.11.3 Observation Context of Quoted Document 25§531

1.4.7.2.11.4 Center POINT 25

1.4.7.2.11.4.1 Reference to node 1.1.5 25

1.4.7.2.11.5 Outline SCOORD 25

1.4.7.2.11.5.1 Reference to node 1.1.5 25

1.4.7.2.11.6 Single Image Finding Individual Calcification 9

1.4.7.2.11.6.1 Rendering Intent Presentation Optional 9

1.4.7.2.11.6.2 Center POINT 25

1.4.7.2.11.6.2.1 Reference to node 1.1.5 25

1.4.7.2.11.6.3 Outline SCOORD 25

1.4.7.2.11.6.3.1 Reference to node 1.1.5 25

1.4.7.2.11.7 Single Image Finding Individual Calcification 9

1.4.7.2.11.7.1 Rendering Intent Presentation Optional 9

1.4.7.2.11.7.2 Center POINT 25

1.4.7.2.11.7.2.1 Reference to node 1.1.5 25

1.4.7.2.11.7.3 Outline SCOORD 25

1.4.7.2.11.7.3.1 Reference to node 1.1.5 25

1.4.7.2.11.8 Single Image Finding Individual Calcification 9

1.4.7.2.11.8.1 Rendering Intent Presentation Optional 9

1.4.7.2.11.8.2 Center POINT 25

1.4.7.2.11.8.2.1 Reference to node 1.1.5 25

1.4.7.2.11.8.3 Outline SCOORD 25

1.4.7.2.11.8.3.1 Reference to node 1.1.5 25

1 Refers to a Supplement 53 Revision 18 template ID; subject to change prior to Supplement 53 approval.

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Part 4 Addendum

Update Annex B and I SOP Class tables

Add Mammography CAD SR Storage SOP Class to Table B.5-1

B.5 STANDARD SOP CLASSES

SOP Class Name SOP Class UID IOD (See PS 3.3)

Mammography CAD SR 1.2.840.10008.5.1.4.1.1.88.34 Mammography CAD SR IOD

B.5.1.5 Structured Reporting Storage SOP Classes

For SOP classes Basic Text SR, Enhanced SR, Comprehensive SR and Mammography CAD SR sSeeAnnex O.

Add Mammography CAD SR Storage Media Storage SOP Classes to Table I.4-1

I.4 MEDIA STANDARD STORAGE SOP CLASSES

SOP Class Name SOP Class UID IOD (See PS 3.3)

Mammography CAD SR 1.2.840.10008.5.1.4.1.1.88.34 Mammography CAD SR IOD

Update Annex O

O.2.x Mammography CAD SR SOP Class

The Mammography CAD SR object contains data not only for presentation to the clinician, but also datasolely for use in subsequent CAD analyses.

The SCU provides rendering guidelines via “Rendering Intent” content items associated with “IndividualImpression/Recommendation”, “Composite Feature” and “Single Image Finding” content items. The fullmeaning of the SR is provided if the tree is rendered down to the first instance of “Not for Presentation” or“Presentation Optional” for each branch of the tree. Use of the SCU’s Conformance Statement isrecommended if further enhancement of the meaning of the SR can be accomplished by rendering someor all of the data marked “Presentation Optional”. Data marked “Not for Presentation” should not berendered by the SCP _ it is embedded in the SR content tree as input to subsequent Mammography CADanalysis work steps.

SCP devices creating human readable text output shall (when available) render content in the mosthuman readable form. For instance, if quadrant and clock-face information is not available as analternate for SCOORD data, then the SCOORD feature location shall be rendered either in (X,Y) pixelcoordinates or (X,Y) in distance units.

O.4.1.x Mammography CAD SR SOP Class

The following shall be documented in the Conformance Statement of any implementation claimingconformance to the Mammography CAD SR SOP Class as an SCU:

• Which algorithms the device is capable of performing:

• From detections listed in CID 99126.1

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• From analyses listed in CID xxxx9

• Which optional content items are supported

• Recommendations to SCPs regarding the rendering of “Presentation Optional” content items

• Recommendations to SCPs regarding how to render to the clinician the “Presentation Required”SCOORD content items

O.4.2.x Mammography CAD SR SOP Class

The following shall be documented in the Conformance Statement of any implementation claimingconformance to the Mammography CAD SR SOP Class as an SCP:

• In what manner the SCP renders the SCOORD content items

• Whether the SCP will render “Presentation Optional” content items

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Part 6 Addendum

ANNEX A (NORMATIVE): REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID)

Add the following UIDs to Part 6 Annex A:

UID Value UID NAME UID TYPE Part

1.2.840.10008.5.1.4.1.1.88.34 Mammography CAD SR SOP Class 3.4

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Part 16 Addendum

ANNEX X: MAMMOGRAPHY CAD SR IOD TEMPLATES

Add the following Templates to Part 16 Annex X:

The templates that comprise the Mammography CAD SR IOD are interconnected as follows:

⟨ ⟨ ⟨

TID nnn1MammographyCAD SRDocument Root

TID nnn19.1DetectionsPerformed

TID nnn19.2AnalysesPerformed

TID nnn2Overallimpression/recommendation

TID nnn20DetectionPerformed

TID nnn21AnalysisPerformed

TID nnn3Impression body

TID nnn4Individualimpression/recommendation

TID nnn3Impression body

TID nnn5Compositefeature

TID nnn9Single imagefinding

TID nnn6Compositefeature body

TID nnn5Compositefeature

TID nnn9Single imagefinding

TID nnn18Image quality

TID nnn11BreastComposition

TID nnn14Density

TID nnn15Nipple

TID nnn16Non-lesion

TID nnn17Selected Region

TID nnn12Breast Geometry

TID nnn13.1IndividualCalcification

⟨ ⟨ ⟨

TID nnn10Generic

TID nnn22Image library

TID nnn25Geometry

TID nnn23.1,23.2, 23.3Measurement

TID nnn21.5AlgorithmIdentification

TID nnn21.5AlgorithmIdentification

TID nnn21.5AlgorithmIdentification

TID nnn21.5AlgorithmIdentification

TID nnn13.2CalcificationCluster

TID nnn25Geometry

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TID nnn1 Mammography CAD SR IOD Document Root Template

This template forms the top of a content tree that allows a CAD device to describe the results of detectionand analysis of Mammographic evidence. This template, together with its subordinate templates,describes both the results for presentation to radiologists and partial product results for consumption byCAD devices in subsequent CAD reports.

This template defines a Container which contains an Image Library, summaries of detection and analysisalgorithms performed, and the CAD results. The Image Library contains the Image SOP Class andInstance UIDs, and selected attributes for each image referenced in either the algorithm summaries orCAD results.

The Summary of Detections and Summary of Analyses Containers gather lists of algorithms attempted,grouped by success/failure status. Algorithms not attempted are not mentioned in these Containers. Thisinformation forms the basis for understanding why a CAD report may produce no (or fewer thananticipated) results. CAD results are constructed bottom-up, starting from Single Image Findings (seeTemplate nnn9), associated as Composite Features (see Template nnn5), and from which Individual andOverall Impressions are formed.

The tree headed by this template is illustrated in Figure x.x.x.1 of Part 3, Annex X (Mammography CADSR Content Tree Structure).

TID nnn1MAMMOGRAPHY CAD SR IOD DOCUMENT ROOT

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CONTAINER (cv, csd, “Mammography CADSR”)

1 M

2 > HAS OBSCONTEXT

INCLUDE ETID (TID nnn59)“Quoted Document RootContext”

1-n MC Required if another document isquoted within this document.

3 > CONTAINS CONTAINER (cv, csd, “Image Library”) 1 M

4 >> CONTAINS INCLUDE ETID (TID nnn22)“Image Library Entry”

1-n M

5 > CONTAINS CODE (cv, csd, “Summary ofDetections”)

1 M ECID (CID xxxx8) “Status ofResults”

6 >> INFERREDFROM

INCLUDE ETID (TID nnn19.1)“Detections Performed”

1 MC Shall be present only if the“Summary of Detections” is not “Not Attempted”

7 > CONTAINS CODE (cv, csd, “Summary ofAnalyses”)

1 M ECID (CID xxxx8) “Status ofResults”

8 >> INFERREDFROM

INCLUDE ETID (TID nnn19.2)“Analyses Performed”

1 MC Shall be present only if the“Summary of Analyses” is not “Not Attempted”

9 > CONTAINS INCLUDE ETID (TID nnn2)“Overall Impression /Recommendation”

1 M

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Content Item Descriptions

Image Library The “Image Library” section of the Content Tree (TID nnn1, row 3) shallinclude all Image SOP Instances from the Current Requested ProcedureEvidence Sequence (0040,A375) attribute of the SR Document Generalmodule. If a portion of another instance of a Mammography CAD SR IOD isquoted in the “Overall Impression/ Recommendation” section of the ContentTree, the “Image Library” shall also include the Image SOP Instances fromthe Pertinent Other Evidence Sequence (0040,A385) attribute of the SRDocument General module that are referenced by the quoted items.

Detections Performed

Analyses Performed

The “Detections Performed” and “Analyses Performed” sections of theContent Tree (TID nnn1, rows 6 and 8) together shall reference all ImageSOP Instances included in the Current Requested Procedure EvidenceSequence (0040,A375) attribute of the SR Document General module.

TID nnn2 Mammography CAD SR IOD Overall Impression/Recommendation Template

This template forms the top of the CAD results sub-tree. The contents of this template describe theoverall impression the CAD device had for the mammographic evidence presented and anyrecommendations that the CAD device made. The details of the impression and recommendation areexpressed in the Impression/Recommendation Body (see TID nnn3). The data from which the details areinferred are expressed in the Individual Impression/Recommendations (see TID nnn4), of which theremay be several.

TID nnn2MAMMOGRAPHY CAD SR IOD OVERALL IMPRESSION/RECOMMENDATION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Overall Impression/Recommendation”)

1 M ECID (CID xxx20) “CADProcessing Summary”

2 > HAS PROP INCLUDE ETID (TID nnn3)“Impression/RecommendationBody”

1 U

3 > INFERREDFROM

INCLUDE ETID (TID nnn4)“IndividualImpression/Recommendation”

1-n MC Shall be present if 1 or moresingle image finding wasdetected

Content Item Descriptions

Overall Impression/Recommendation

This code value is used to express if and why the OverallImpression/Recommendation sub-tree is empty. The Summary of Detectionsand Summary of Analyses sub-trees of the Document Root node containdetail about which (if any) algorithms succeeded or failed.

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TID nnn3 Mammography CAD SR IOD Impression/Recommendation Body Template

The details of an impression and recommendation are expressed in this template. It is applied to bothOverall Impression/Recommendation (TID nnn2) and Individual Impression/Recommendation (TID nnn4).

TID nnn3MAMMOGRAPHY CAD SR IOD IMPRESSION/RECOMMENDATION BODY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “AssessmentCategory”)

1 MC At least one of elements 1, 2, 3,4, 5, 6 shall be present.

ECID (CID 99135)“Assessment”

2 CODE (cv, csd, “DifferentialDiagnosis/ Impression”)

1-n MC At least one of elements 1, 2, 3,4, 5, 6 shall be present.

DCID (CID 99117) “ChangeSince Last Mammogram orPrior Surgery”

3 TEXT (cv, csd, “Impressiondescription”)

1 MC At least one of elements 1, 2, 3,4, 5, 6 shall be present.

4 CODE (cv, csd, “RecommendedFollow-up”)

1-n MC At least one of elements 1, 2, 3,4, 5, 6 shall be present.

DCID (CID 99136)“Recommended Follow-up”

5 NUM (cv, csd, “RecommendedFollow-up Interval”)

1 MC At least one of elements 1, 2, 3,4, 5, 6 shall be present. May bepresent only if “RecommendedFollow-up Date” is not present.

UNITS = DCID (CID xxx12)“Units of Follow-up Interval”;Values = Integer ≥ 0

6 DATE (cv, csd, “RecommendedFollow-up Date”)

1 MC At least one of elements 1, 2, 3,4, 5, 6 shall be present. May bepresent only if “RecommendedFollow-up Interval” is not present.

Shall be later than date ofexam

7 NUM (cv, csd, “Certainty ofimpression”)

1 UC May be present only if“Assessment Category”,“DifferentialDiagnosis/Impression” or“Impression Description” ispresent.

UNITS = (cv, csd, “Percent”)Values = 0 – 100

Content Item Descriptions

Certainty of Impression The certainty that the device populating the Mammography CAD SR reportplaces on this impression, where 0 equals no certainty and 100 equalsassurance.

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TID nnn4 Mammography CAD SR IOD Individual Impression/Recommendation Template

This template collects an individual impression the CAD device had for a lesion, non-lesion object, orcorrelation of related objects. The details of the impression and recommendation are expressed in theImpression/Recommendation Body (see TID nnn3). The data from which the details are inferred areexpressed in the Composite Features (see TID nnn5) and/or Single Image Findings (see TID nnn9) ofwhich there may be several.

The sub-tree headed by this template is illustrated in Figure x.x.x.3 of Part 3, Annex X (MammographyCAD SR Content Tree Structure).

TID nnn4MAMMOGRAPHY CAD SR IOD INDIVIDUAL IMPRESSION/RECOMMENDATION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “IndividualImpression/Recommendation”)

1 M EV (cv, csd, “INDIVIDUAL”)

2 > HAS PROP CODE (cv, csd, “Rendering Intent”) 1 M ECID (CID xxxx1) “IntendedUse of CAD Output”

3 > HAS PROP INCLUDE ETID (TID nnn3)“Impression /Recommendation Body”

1 U

4 > INFERREDFROM

INCLUDE ETID (TID nnn5)“Composite Feature”

1-n U

5 > INFERREDFROM

INCLUDE ETID (TID nnn9)“Single Image Finding”

1-n U

Content Item Descriptions

Rendering Intent This content item constrains the SCP receiving the Mammography CAD SRIOD in its use of the contents of this template and its target content items.CAD devices may opt to use data marked “Not for Presentation” or“Presentation Optional” as input to subsequent CAD processing steps.

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TID nnn5 Mammography CAD SR IOD Composite Feature Template

This template collects a composite feature for a lesion, non-lesion object, or correlation of related objects.The details of the composition are expressed in the Composite Feature Body (see TID nnn6). The datafrom which the details are inferred are expressed in the Composite Features (see TID nnn5) and/or SingleImage Findings (see TID nnn9) of which there may be several.

A Composite Feature shall be INFERRED FROM any combination of two or more Composite Features orSingle Image Findings or mixture thereof.

TID nnn5MAMMOGRAPHY CAD SR IOD COMPOSITE FEATURE

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Composite Feature”) 1 M ECID (CID 99126.2)“Composite Feature”

2 > HAS PROP INCLUDE ETID (TID nnn6)“Composite Feature Body”

1 M

3 > INFERREDFROM

INCLUDE ETID (TID nnn5)“Composite Feature”

1-n U

4 > INFERREDFROM

INCLUDE ETID (TID nnn9)“Single Image Finding”

1-n U

5 > HAS OBSCONTEXT

INCLUDE ETID (TID 25) 1 MC Shall be present only if thisfeature is quoted from adifferent report.

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TID nnn6 Mammography CAD SR IOD Composite Feature Body Template

The details of a composite feature are expressed in this template. It is applied to Composite Feature (TIDnnn5).

TID nnn6MAMMOGRAPHY CAD SR IOD COMPOSITE FEATURE BODY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Composite type”) 1 M ECID (CID xxxx2) “CompositeFeature Relations “. The valueshall be “contra-lateral” if theparent content item has codevalue “Focal AsymmetricDensity” or “Asymmetric BreastTissue”.

2 CODE (cv, csd, “Scope of Feature”) 1 M ECID (CID xxxx3) “Scope ofFeature”

3 CODE (cv, csd, “Rendering Intent”) 1 M ECID (CID xxxx1) “IntendedUse of CAD Output”

4 INCLUDE ETID (TID nnn21.5)“Algorithm Identification”

1 M

5 NUM (cv, csd, “Certainty of feature”) 1 U UNITS = (cv, csd, “Percent”)Value = 0 – 100

6 NUM (cv, csd, “Probability ofcancer”)

1 UC May be present only if parent isnot “Non-lesion”

UNITS = (cv, csd, “Percent”)Value = 0 – 100

7 CODE (cv, csd, “Pathology”) 1 U DCID (CID 99143) “PathologyCodes”

8 CODE (cv, csd, “LinearMeasurement”)

1-n U ECID (CID xxx16) “LinearMeasurements”

9 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

10 CODE (cv, csd, “Area Measurement”) 1-n U ECID (CID xxx17) “AreaMeasurements”

11 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

12 CODE (cv, csd, “VolumeMeasurement”)

1-n U ECID (CID xxx18) “VolumeMeasurements”

13 > HAS PROP INCLUDE ETID (TID nnn23.3)“Volume Measurement”

1 M

14 INCLUDE ETID (TID nnn25)“Geometry”

1-n U

15 CODE (cv, csd, “QuantitativeDifference”)

1-n UC May be present only if“Composite type” is “temporal”

DCID (CID xxxx4) “QuantitativeTemporal Difference Type”

16 > HAS PROP NUM (cv, csd, “Difference value A-B”)

1 M UNITS = DCID (CID xxx19)“Units of 1D, 2D and 3DMeasurement” or (cv, csd,“Null”)

17 > R-INFERREDFROM

NUM 2 M The referenced numeric valuesshall have the same ConceptName. Their UNITS shall bethe same as “Difference valueA-B”

18 CODE (cv, csd, “QualitativeDifference”)

1-n UC May be present only if“Composite type” is “temporal”

DCID (CID xxxx4.1)“Qualitative TemporalDifference Type”

19 > HAS PROP TEXT (cv, csd, “Description ofChange”)

1 M

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NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

20 > R-INFERREDFROM

CODE 2 M The referenced code valuesshall have the same ConceptName and be from the samecontext group.

21 CODE (cv, csd, “Quadrant location”) 1 U ECID (CID 99132) “QuadrantLocation”

22 CODE (cv, csd, “Clockface or region”)1 U ECID (CID 99131) “ClockfaceLocation”

23 CODE (cv, csd, “Depth”) 1 U DCID (CID 99134) “Depth”

24 CODE (cv, csd, “Lesion density”) 1 UC May be present only if parent is“Mass” or “Density”

DCID (CID 99120) “DensityModifier”

25 CODE (cv, csd, “Shape”) 1 UC May be present only if parent is“Mass” or “Density”

DCID (CID 99118)“Characteristics of Shape”

26 CODE (cv, csd, “Margins”) 1-n UC May be present only if parent is“Mass” or “Density”

DCID (CID 99119)“Characteristics of Margin”

27 CODE (cv, csd, “Calcification Type”) 1-n UC May be present only if parent is“Calcification Cluster” or“Individual Calcification”

DCID (CID 99121)“Calcification Types”

28 CODE (cv, csd, “CalcificationDistribution”)

1 UC May be present only if parent is“Calcification Cluster”

DCID (CID 99122)“Calcification DistributionModifier”

29 NUM (cv, csd, “Number ofcalcifications”)

1 UC May be present only if parent is“Calcification Cluster”

UNITS = (cv, csd, “Null”)Value = Integer 1 – n

Content Item Descriptions

Rendering Intent This content item constrains the SCP receiving the Mammography CAD SRIOD in its use of the contents of this template and its target content items.CAD devices may opt to use data marked “Not for Presentation” or“Presentation Optional” as input to subsequent CAD processing steps.

Certainty of Feature The likelihood that the feature analyzed, and classified by the CODE specifiedin the Composite Feature parent template, is in fact that type of feature.

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TID nnn9 Mammography CAD SR IOD Single Image Finding Template

This template collects a single image finding for a lesion or other object. The details of the finding areexpressed in the Single Image Finding Generic (see TID nnn10) and/or more specific templates. Thedetails from which a single image Calcification Cluster is inferred may be expressed in a number of SingleImage Findings (see TID nnn9) of type Individual Calcification.

A Single Image Finding of type Breast Composition may be INFERRED FROM by-reference to a SingleImage Finding of type Breast Geometry.

TID nnn9MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Single ImageFinding”)

1 M ECID (CID 99126.1) “SingleImage Finding”

2 > HAS PROP CODE (cv, csd, “Rendering Intent”) 1 M ECID (CID xxxx1) “IntendedUse of CAD Output”

3 > HAS PROP INCLUDE ETID (TID nnn21.5)“Algorithm Identification”

1 M

4 > HAS PROP INCLUDE ETID (TID nnn10)“Single Image FindingGeneric”

1 MC Shall be present only if parent isnot “Breast composition”,“Breast geometry”, “Nipple”,“Selected region” or “Imagequality”

5 > HAS PROP INCLUDE ETID (TID nnn11)“Single Image Finding BreastComposition”

1 MC Shall be present only if parent is“Breast composition”

6 > R-INFERREDFROM

CODE (cv, csd, “Single ImageFinding”)

1-n UC May be present only if parent is“Breast composition”

EV (cv, csd, “BreastGeometry”) from CID 99126.1

7 > HAS PROP INCLUDE ETID (TID nnn12)“Single Image Finding BreastGeometry”

1 MC Shall be present only if parent is“Breast geometry”

8 > HAS PROP INCLUDE EDIT (TID nnn13.1)“Single Image FindingIndividual Calcification”

1 UC May be present only if parent is“Individual Calcification”

9 > HAS PROP INCLUDE ETID (TID nnn13.2)“Single Image FindingCalcification Cluster”

1 UC May be present only if parent is“Calcification Cluster”

10 > HAS PROP INCLUDE ETID (TID nnn14)“Single Image FindingDensity”

1 UC May be present only if parent is“Density”

11 > HAS PROP INCLUDE ETID (TID nnn15)“Single Image Finding Nipple”

1 MC Shall be present only if parent is“Nipple”

12 > HAS PROP INCLUDE ETID (TID nnn16)“Single Image Finding Non-Lesion”

1 MC Shall be present only if parent is“Non-lesion”

13 > HAS PROP INCLUDE ETID (TID nnn17)“Selected Region”

1 MC Shall be present only if parent is“Selected Region”

14 > HAS PROP INCLUDE ETID (TID nnn18)“Single Image Finding ImageQuality”

1 MC Shall be present only if parent is“Image quality”

15 > INFERREDFROM

INCLUDE ETID (TID nnn9)“Single Image Finding”

1-n UC May be present only if parent is“Calcification Cluster”

EV (cv, csd, “IndividualCalcification”) from CID99126.1

16 > HAS OBSCONTEXT

INCLUDE ETID (TID 25) 1 MC Shall be present only if thisfinding is quoted from adifferent report.

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Content Item Descriptions

Rendering Intent This content item constrains the SCP receiving the Mammography CAD SRIOD in its use of the contents of this template and its target content items.CAD devices may opt to use data marked “Not for Presentation” or“Presentation Optional” as input to subsequent CAD processing steps.

Single Image Finding A Single Image Finding (whose parent is a Single Image Finding of typeCalcification Cluster) allows one level of nesting for the definition of individualcalcifications within the cluster. To use this template recursively, this SingleImage Finding code value shall be “Individual Calcification”.

TID nnn10 Mammography CAD SR IOD Single Image Finding Generic Template

The details of a single image finding are expressed in this template. It is applied to Single Image Findings(TID nnn9) of all types (CID 99126.1) except “Breast composition”, “Breast geometry”, “Nipple”, “Selectedregion” and “Image quality”.

TID nnn10MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING GENERIC

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 NUM (cv, csd, “Certainty ofFinding”)

1 U UNITS = (cv, csd, “Percent”)Value = 0 – 100

2 NUM (cv, csd, “Probability ofCancer”)

1 UC May be present only if parent isnot “Non-lesion”

UNITS = (cv, csd, “Percent”)Value = 0 – 100

3 INCLUDE ETID (TID nnn25)“Geometry”

1 M

Content Item Descriptions

Certainty of Finding The likelihood that the finding detected, and classified by the CODE specifiedin the Single Image Finding parent template, is in fact that type of finding.

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TID nnn11 Mammography CAD SR IOD Single Image Finding Breast Composition Template

TID nnn11MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING BREAST COMPOSITION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 NUM (cv, csd, “Certainty ofFinding”)

1 U UNITS = (cv, csd, “Percent”)Value = 0 – 100

2 CODE (cv, csd, “BreastComposition”)

1 MC At least one of “PercentGlandular Tissue” or “BreastComposition” shall be present

DCID (CID 99115) “OverallBreast Composition”

3 NUM (cv, csd, “Percent GlandularTissue”)

1 MC At least one of “PercentGlandular Tissue” or “BreastComposition” shall be present

UNITS = (cv, csd, “Percent”)Value = 0 – 100

Content Item Descriptions

Certainty of Finding The likelihood that the finding detected (CID 99115) is in fact that type offinding.

Percent GlandularTissue

Percent of breast area that is mammographically dense

TID nnn12 Mammography CAD SR IOD Single Image Finding Breast Geometry Template

TID nnn12MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING BREAST GEOMETRY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 SCOORD (cv, csd, “Breast OutlineIncluding Pectoral MuscleTissue”)

1 M Graphic Data Type =POLYLINE

2 > R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

3 SCOORD (cv, csd, “Pectoral MuscleOutline”)

1 U Graphic Data Type =POLYLINE

4 > R-SELECTEDFROM

IMAGE 1 M Shall reference the same nodeas Element 2

Content Item Descriptions

Breast Outline IncludingPectoral Muscle Tissue

<Insert illustration here>

Pectoral Muscle Outline <Insert illustration here>

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TID nnn13.1 Mammography CAD SR IOD Single Image Finding Individual Calcification Template

This template provides the detail specific to an individual calcification.

TID nnn13.1MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING INDIVIDUAL CALCIFICATION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Calcification type”) 1-n MC At least one of elements 1, 2, 4shall be present

DCID (CID 99121)“Calcification Types”

2 CODE (cv, csd, “LinearMeasurement”)

1-n MC At least one of elements 1, 2, 4shall be present

ECID (CID xxx16) “LinearMeasurements”

3 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

4 CODE (cv, csd, “Area Measurement”) 1-n MC At least one of elements 1, 2, 4shall be present

ECID (CID xxx17) “AreaMeasurements”

5 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

TID nnn13.2 Mammography CAD SR IOD Single Image Finding Calcification Cluster Template

This template provides the detail specific to a calcification cluster.

TID nnn13.2MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING CALCIFICATION CLUSTER

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Calcification type”) 1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

DCID (CID 99121)“Calcification Types”

2 CODE (cv, csd, “Calcificationdistribution”)

1 MC At least one of elements 1, 2, 3,4, 6 shall be present

DCID (CID 99122)“Calcification DistributionModifier”

3 NUM (cv, csd, “Number ofcalcifications”)

1 MC At least one of elements 1, 2, 3,4, 6 shall be present

UNITS = (cv, csd, “Null”)Value = Integer >= 1

4 CODE (cv, csd, “LinearMeasurement”)

1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

ECID (CID xxx16) “LinearMeasurements”

5 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

6 CODE (cv, csd, “Area Measurement”) 1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

ECID (CID xxx17) “AreaMeasurements”

7 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

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TID nnn14 Mammography CAD SR IOD Single Image Finding Density Template

This template provides the detail specific to a density.

TID nnn14MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING DENSITY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Lesion density”) 1 MC At least one of elements 1, 2, 3,4, 6 shall be present

DCID (CID 99120) “DensityModifier”

2 CODE (cv, csd, “Shape”) 1 MC At least one of elements 1, 2, 3,4, 6 shall be present

DCID (CID 99118)“Characteristics of Shape”

3 CODE (cv, csd, “Margins”) 1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

DCID (CID 99119)“Characteristics of Margin”

4 CODE (cv, csd, “LinearMeasurement”)

1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

ECID (CID xxx16) “LinearMeasurements”

5 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

6 CODE (cv, csd, “Area Measurement”) 1-n MC At least one of elements 1, 2, 3,4, 6 shall be present

ECID (CID xxx17) “AreaMeasurements”

7 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

TID nnn15 Mammography CAD SR IOD Single Image Finding Nipple Template

This template provides the detail specific to a nipple.

TID nnn15MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING NIPPLE

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Nipple Status”) 1 U DCID (CID xxxx5) “NippleStatus”

2 SCOORD (cv, csd, “Nipple Center”) 1 M Graphic Data Type = POINT

3 > R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Nipple Center <Insert illustration here>

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TID nnn16 Mammography CAD SR IOD Single Image Finding Non-Lesion Template

This template provides the detail specific to a finding other than a lesion (see CID xxxx6).

TID nnn16MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING NON-LESION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “Object type”) 1 M DCID (CID xxxx6) “Non-LesionObject Type”

2 CODE (cv, csd, “LinearMeasurement”)

1-n U ECID (CID xxx16) “LinearMeasurements”

3 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

4 CODE (cv, csd, “Area Measurement”) 1-n U ECID (CID xxx17) “AreaMeasurements”

5 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

TID nnn17 Mammography CAD SR IOD Single Image Finding Selected Region Template

This template provides the detail specific to a selected region. A selected region is any CAD derivedarbitrary region of the image, whether within the breast outline or not. This can be use to delineateregions such as the intramammary fold.

TID nnn17MAMMOGRAPHY CAD SR IOD SELECTED REGION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “Selected RegionDescription”)

1 M

2 INCLUDE ETID (TID nnn25)“Geometry”

1 M

3 CODE (cv, csd, “LinearMeasurement”)

1-n U ECID (CID xxx16) “LinearMeasurements”

4 > HAS PROP INCLUDE ETID (TID nnn23.1)“Linear Measurement”

1 M

5 CODE (cv, csd, “Area Measurement”) 1-n U ECID (CID xxx17) “AreaMeasurements”

6 > HAS PROP INCLUDE ETID (TID nnn23.2)“Area Measurement”

1 M

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TID nnn18 Mammography CAD SR IOD Single Image Finding Image Quality Template

This template provides the detail specific to image quality. It allows the encoding of descriptors of imagequality (CID xxxx7) for a given image or region of an image. For instance, images with partial motion blurcan be identified with the region noted.

TID nnn18MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING IMAGE QUALITY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 R- IMAGE 1 MC Shall be present only if “ImageRegion” is not present

Shall reference an “ImageUsed As Evidence”

2 SCOORD (cv, csd, “Image Region”) 1-n MC Shall be present only if Element1 is not present

3 > R-SELECTEDFROM

IMAGE 1 M Each “Image Region” shallreference the same “ImageUsed As Evidence”

4 NUM (cv, csd, “Certainty ofFinding”)1

1 U UNITS = (cv, csd, “Percent”)Value = 0 – 100

5 CODE (cv, csd, “Quality Finding”) 1 M DCID (CID xxxx7) “ImageQuality Finding”

6 CODE (cv, csd, “Quality ControlStandard”)

1 U DCID (CID xxx11) “Types ofQuality Control Standard”

7 CODE (cv, csd, “QualityAssessment”)

1 U DCID (CID xxx10) “Types ofImage Quality Assessment”

8 NUM (cv, csd, “Image QualityRating”)2

1 U UNITS = (cv, csd, “Null”)Value = 0 – 100

Content Item Descriptions

Certainty of Finding The likelihood that the finding detected (CID xxxx7) is in fact that type offinding.

Image Quality Rating A numeric value in the range 0 to 100, inclusive, where 0 is poor quality and100 is best quality.

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TID nnn19.1 Mammography CAD SR IOD Detections Performed Template

This template gathers two lists of detection algorithms attempted, grouped by success/failure status.Algorithms not attempted are not mentioned in this sub-tree of the Document Root (TID nnn1). Thisinformation forms the basis for understanding why a CAD report may produce no (or fewer thananticipated) detection results.

The sub-tree formed by this template is illustrated in Figure x.x.x.2 of Part 3, Annex X (MammographyCAD SR Content Tree Structure).

TID nnn19.1MAMMOGRAPHY CAD SR IOD DETECTIONS PERFORMED

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “SuccessfulDetections”)

1 MC Shall be present only if parent is“Succeeded” or “PartiallySucceeded”

NULL

2 > HAS PROP INCLUDE ETID (TID nnn20)“Detection Performed”

1-n M

3 TEXT (cv, csd, “Failed Detections”) 1 MC Shall be present only if parent is“Failed” or “PartiallySucceeded”

NULL

4 > HAS PROP INCLUDE ETID (TID nnn20)“Detection Performed”

1-n M

TID nnn19.2 Mammography CAD SR IOD Analyses Performed Template

This template gathers two lists of analysis algorithms attempted, grouped by success/failure status.Algorithms not attempted are not mentioned in this sub-tree of the Document Root (TID nnn1). Thisinformation forms the basis for understanding why a CAD report may produce no (or fewer thananticipated) analysis results.

The sub-tree formed by this template is illustrated in Figure x.x.x.2 of Part 3, Annex X (MammographyCAD SR Content Tree Structure).

TID nnn19.2MAMMOGRAPHY CAD SR IOD ANALYSES PERFORMED

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “SuccessfulAnalyses”)

1 MC Shall be present only if parent is“Succeeded” or “PartiallySucceeded”

NULL

2 > HAS PROP INCLUDE ETID (TID nnn21)“Analysis Performed”

1-n M

3 TEXT (cv, csd, “Failed Analyses”) 1 MC Shall be present only if parent is“Failed” or “PartiallySucceeded”

NULL

4 > HAS PROP INCLUDE ETID (TID nnn21)“Analysis Performed”

1-n M

TID nnn20 Mammography CAD SR IOD Detection Performed Template

This template fully identifies a detection algorithm and the images and/or image regions on which itoperated.

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TID nnn20MAMMOGRAPHY CAD SR IOD DETECTION PERFORMED

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “DetectionPerformed”)

1 M DCID (CID 99126.1) “SingleImage Finding”

2 > HAS PROP INCLUDE ETID (TID nnn21.5)“Algorithm Identification”

1 M

3 > R-HASPROP

IMAGE 1-n MC At least one of Element 3 or“Image Region” shall be present

Shall reference an “ImageUsed As Evidence”

4 > HAS PROP SCOORD (cv, csd, “Image Region”) 1-n MC At least one of Element 3 or“Image Region” shall be present

5 >> R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Algorithm Identification If more than one detection algorithm has the same “Detection Performed”code value (CID 99126.1) then the “Algorithm Identification” shallunambiguously distinguish between algorithms.

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TID nnn21 Mammography CAD SR IOD Analysis Performed Template

This template fully identifies an analysis algorithm and the images and/or image regions on which itoperated.

TID nnn21MAMMOGRAPHY CAD SR IOD ANALYSIS PERFORMED

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 CODE (cv, csd, “AnalysisPerformed”)

1 M DCID (CID xxxx9) “Types ofCAD Analysis Performed”

2 > HAS PROP INCLUDE ETID (TID nnn21.5)“Algorithm Identification”

1 M

3 > R-HASPROP

IMAGE 1-n MC A total of at least two instancesof Element 3 or “Image Region”shall be present

Shall reference an “ImageUsed As Evidence”

4 > HAS PROP SCOORD (cv, csd. “Image Region”) 1-n MC At total of at least two instancesof Element 3 or “Image Region”shall be present

5 >> R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Algorithm Identification If more than one analysis algorithm has the same “Analysis Performed” codevalue (CID xxxx9) then the “Algorithm Identification” shall unambiguouslydistinguish between algorithms.

TID nnn21.5 Mammography CAD SR IOD Algorithm Identification Template

This template details the algorithm unambiguously. Re-state the software identification from the GeneralEquipment Module of the Mammography CAD SR IOD if all algorithms are unambiguously defined by thatmodule.

TID nnn21.5MAMMOGRAPHY CAD SR IOD ALGORITHM IDENTIFICATION

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “Algorithm ID”) 1 M

2 TEXT (cv, csd, “Algorithm Version”) 1 M

3 TEXT (cv, csd, “AlgorithmParameters”)

1-n U

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TID nnn22 Mammography CAD SR IOD Image Library Entry Template

Each instance of the Image Library Entry template contains the Image SOP Class and Instance UIDs, andselected attributes for an image. If the Image SOP Class is other than Digital Mammography ImageStorage then as many of the attributes as possible should be derived.

TID nnn22MAMMOGRAPHY CAD SR IOD IMAGE LIBRARY ENTRY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 IMAGE (cv, csd, “Image Used AsEvidence”)

1 M

2 > HAS ACQCONTEXT

CODE (cv, csd, “Image Laterality”) 1 MC Shall be present if (0020,0062)is in “Image Used As Evidence”

ECID (CID 99133) “Side”

3 > HAS ACQCONTEXT

CODE (cv, csd, “Image View CodeSequence”)

1 MC Shall be present if (0054,0220)is in “Image Used As Evidence”

ECID (CID 4014) “View forMammography”

4 > HAS ACQCONTEXT

CODE (cv, csd, “Image View CodeModifier Sequence”)

1 MC Shall be present if (0054,0222)is in “Image Used As Evidence”

ECID (CID 4015) “ViewModifier for Mammography”

5 > HAS ACQCONTEXT

TEXT (cv, csd, “Patient OrientationRow”)

1 MC Shall be present if (0020,0020)is in “Image Used As Evidence”

6 > HAS ACQCONTEXT

TEXT (cv, csd, “Patient OrientationColumn”)

1 MC Shall be present if (0020,0020)is in “Image Used As Evidence”

7 > HAS ACQCONTEXT

DATE (cv, csd, “Study Date”) 1 MC Shall be present if (0008,0020)is in “Image Used As Evidence”

8 > HAS ACQCONTEXT

TIME (cv, csd, “Study Time”) 1 MC Shall be present if (0008,0030)is in “Image Used As Evidence”

9 > HAS ACQCONTEXT

DATE (cv, csd, “Content Date”) 1 MC Shall be present if (0008,0023)is in “Image Used As Evidence”

10 > HAS ACQCONTEXT

TIME (cv, csd, “Content Time”) 1 MC Shall be present if (0008,0033)is in “Image Used As Evidence”

11 > HAS ACQCONTEXT

NUM (cv, csd, “Horizontal ImagerPixel Spacing”)

1 MC Shall be present if (0018,1164)is in “Image Used As Evidence”

EV (cv, csd, “_m”)

12 > HAS ACQCONTEXT

NUM (cv, csd, “Vertical Imager PixelSpacing”)

1 MC Shall be present if (0018,1164)is in “Image Used As Evidence”

EV (cv, csd, “_m”)

Content Item Descriptions

Patient Orientation Row

Patient OrientationColumn

First (row) and Second (column) components of Patient Orientation(0020,0020) in “Image Used As Evidence”. See PS 3, C.7.6.1.1.1.

Horizontal Imager PixelSpacing

The row (first) component of Imager Pixel Spacing (0018,1164) in “ImageUsed As Evidence”. See PS 3, C.8.11.4. If the source spacing is notmicrons, convert it.

Vertical Imager PixelSpacing

The column (second) component of Imager Pixel Spacing (0018,1164) in“Image Used As Evidence”. See PS 3, C.8.11.4. If the source spacing is notmicrons, convert it.

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TID nnn23.1 Mammography CAD SR IOD Linear Measurement Template

TID nnn23.1MAMMOGRAPHY CAD SR IOD LINEAR MEASUREMENT

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “MeasurementName”)

1 M

2 NUM (cv, csd, “Path length”) 1 M UNITS = DCID (CID xxx13)“Units of Linear Measurement”

3 > INFERREDFROM

SCOORD (cv, csd, “Path”) 1 M

4 >> R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Path Path can be a POLYLINE with two points (to measure length, diameter,distance, proximity, etc), a CIRCLE or ELLIPSE (to measure circumference)or a POLYLINE (open or closed) to measure polyline length or perimeter. AGraphic Data Type of POINT implies that the object is a single pixel.

TID nnn23.2 Mammography CAD SR IOD Area Measurement Template

TID nnn23.2MAMMOGRAPHY CAD SR IOD AREA MEASUREMENT

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “MeasurementName”)

1 M

2 NUM (cv, csd, “Area”) 1 M UNITS = DCID (CID xxx14)“Units of Area Measurement”

3 > INFERREDFROM

SCOORD (cv, csd, “Area Outline”) 1 MC Shall be present if code value ofparent of “Area” is “Area ofDefined Region”

4 >> R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Area Outline A Graphic Data Type of POINT implies that the object is a single pixel.

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TID nnn23.3 Mammography CAD SR IOD Volume Measurement Template

TID nnn23.3MAMMOGRAPHY CAD SR IOD VOLUME MEASUREMENT

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 TEXT (cv, csd, “MeasurementName”)

1 M

2 NUM (cv, csd, “Volume”) 1 M UNITS = DCID (CID xxx15)“Units of VolumeMeasurement”

3 > INFERREDFROM

SCOORD (cv, csd, “Perimeter Outline”) 1-n U

4 >> R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

Content Item Descriptions

Perimeter Outline The perimeter of the volume’s projection into the image.

TID nnn25 Mammography CAD SR IOD Geometry Template

TID nnn25MAMMOGRAPHY CAD SR IOD GEOMETRY

NL Rel withParent

VT Concept Name VM ReqType

Condition Value Set Constraint

1 SCOORD (cv, csd, “Center”) 1 M Graphic Data Type = POINT

2 > R-SELECTEDFROM

IMAGE 1 M Shall reference an “ImageUsed As Evidence”

3 SCOORD (cv, csd, “Outline”) 1 U

4 > R-SELECTEDFROM

IMAGE 1 M Shall reference the same nodeas Element 2

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ANNEX Y: MAMMOGRAPHY CAD SR IOD ADOPTIVE TERMINOLOGY AND NOMENCLATURE

BI-RADS Terminology and Nomenclature:

Terminology used within the Mammography CAD SR SOP Class is a superset of BI-RADS Revision 3,a trademarked lexicon of Mammography screening terminology and nomenclature licensed by DICOMfrom the American College of Radiology. BI-RADS publications are available from the American Collegeof Radiology. The DICOM standard does not require Mammography CAD SR SOP Classimplementations to adhere to BI-RADS.

MQCM 1999 Terminology and Nomenclature

References to MQCM 1999 are made in the description of the Mammography CAD SR SOP Class. Inthis MQCM 1999 refers to the Mammography Quality Control Manual 1999, available from the AmericanCollege of Radiology. This document describes a standardized approach to mammographic acquisitionstandards, patient positioning, and so on. The DICOM standard does not require Mammography CAD SRSOP Class implementations to adhere to MQCM 1999.

MQSA Terminology and Nomenclature

References to MQSA are made in the description of the Mammography CAD SR SOP Class. In thisMQSA refers to the Mammography Quality Standards Act final rules. While MQSA is a federal regulationof the United States government, it provides the only widely published standards for mammographicquality and is incorporated in this document for that reason. The DICOM standard does not requireMammography CAD SR SOP Class implementations to adhere to MQSA.

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ANNEX Z: MAMMOGRAPHY CAD SR IOD MICROGLOSSARY

The following tables provide context identification (Context Id) information derived from SNOMED forDICOM.

CONTEXT GROUP 99115 – Overall Breast CompositionNote from National Mammography Database (BI-RADSTM 3.0, E77)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Almost entirely fat

Scattered fibroglandular densities

Heterogeneously dense

Extremely dense

CONTEXT GROUP 99117 – Change Since Last Mammogram or Prior SurgeryNote from National Mammography Database (BI-RADSTM 3.0, E79)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

New finding

Finding partially removed

No significant changes in the finding

Increase in size

Decrease in size

Increase in number of calcifications

Decrease in number of calcifications

Less defined

More defined

Implant removed

Implant revised

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CONTEXT GROUP 99118 – Characteristics of ShapeNote from National Mammography Database (BI-RADSTM 3.0, E80)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Round

Oval

Lobular

Irregular

CONTEXT GROUP 99119 – Characteristics of MarginNote from National Mammography Database (BI-RADSTM 3.0, E81)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Circumscribed (well-defined or sharply-defined)

Microlobulated

Obscured

Indistinct

Spiculated

CONTEXT GROUP 99120 – Density ModifierNote from National Mammography Database (BI-RADSTM 3.0, E82)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

High density

Equal density (isodense)

Low density (not containing fat)

Fat containing (radiolucent)

CONTEXT GROUP 99121 – Calcification TypesNote from National Mammography Database (BI-RADSTM 3.0, E83)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Coarse (popcorn-like)

Dystrophic

Eggshell or rim

Large rod-like

Milk of calcium

Lucent-centered

Punctate

Round

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Skin

Suture

Vascular

Amorphous or indistinct

Fine, linear (casting)

Fine, linear, branching (casting)

Heterogeneous or pleomorphic

CONTEXT GROUP 99122 – Calcification Distribution ModifierNote from National Mammography Database (BI-RADSTM 3.0, E84)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Diffuse/scattered

Linear

Grouped or clustered

Regional

Segmental

CONTEXT GROUP 99126.1 – Single Image FindingNote from National Mammography Database (BI-RADSTM 3.0)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Density

Individual Calcification

Calcification Cluster

Architectural distortion

Tubular density

Intra-mammary lymph node

Trabecular thickening

Selection region

Breast composition

Breast geometry

Nipple

Skin retraction

Skin thickening

Axillary adenopathy

Skin lesion

Non-lesion

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Image Quality

CONTEXT GROUP 99126.2 – Composite FeatureNote from National Mammography Database (BI-RADSTM 3.0)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Include CONTEXT GROUP 99126.1

Mass

Focal asymmetric breast tissue

Asymmetric breast tissue

CONTEXT GROUP 99131 – Clockface LocationNote from National Mammography Database (BI-RADSTM 3.0, E96)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

1 o’clock (1)

2 o’clock (2)

3 o’clock (3)

4 o’clock (4)

5 o’clock (5)

6 o’clock (6)

7 o’clock (7)

8 o’clock (8)

9 o’clock (9)

10 o’clock (10)

11 o’clock (11)

12 o’clock (12)

Subareolar (S)

Axillary tail (T)

Central (C)

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CONTEXT GROUP 99132 – Quadrant LocationNote from National Mammography Database (BI-RADSTM 3.0, E97)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Upper outer (UO)

Upper inner (UI)

Lower outer (LO)

Lower inner (LI)

CONTEXT GROUP 99133 – SideNote from National Mammography Database (BI-RADSTM 3.0, E98)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Left

Right

Both

CONTEXT GROUP 99134 – DepthNote from National Mammography Database (BI-RADSTM 3.0, E99)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Anterior

Middle

Posterior

CONTEXT GROUP 99135 – AssessmentNote from National Mammography Database (BI-RADSTM 3.0, E100)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

0 - Need additional imaging evaluation

1 – Negative

2 – Benign

3 - Probably benign – short interval follow-up (1-11months)

4 - Suspicious abnormality, biopsy should beconsidered

5 - Highly suggestive of malignancy, takeappropriate action

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CONTEXT GROUP 99136 – Recommended Follow-upNote from National Mammography Database (BI-RADSTM 3.0, E101) for Assessment Category 0

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Additional projections (P)

Magnification views (M)

Spot compression (S)

Spot magnification (V)

Ultrasound (U)

Old films for comparison (O)

Ductography (G)

Normal interval follow-up (N)

Decision to biopsy should be based on clinicalassessment

Follow-up at short interval (1-11 months) (F)

Biopsy should be considered (B)

Needle localization and biopsy (L)

Histology using core biopsy (H)

Suggestive of malignancy – take appropriate action(T)

Cytologic analysis (Y)

CONTEXT GROUP 99143 – Pathology CodesNote from National Mammography Database (BI-RADSTM 3.0, F110)

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Papilloma

Adenomyoepithelioma

Mixed tumor (pleomorphic adenoma)

Ductal adenoma

Florid papillomatosis (adenoma) of the nipple

Tubular adenoma

Lactating adenoma

Apocrine adenoma

Fibroadenoma

Fibroadenoma, NOS

Juvenile fibroadenoma

Benign cystosarcoma phyllodes (phyllodes tumor)

Hemangioma

Perilobular hemangioma

Hemangioma NOS

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Venous hemangioma

Nonparenchymal subcutaneous hemangioma

Angiomatosis

Fibromatosis

Myofibroblastoma

Neurofibroma

Leiomyoma

Lipoma

Adenolipoma

Angiolipoma

Chondroma

Granular cell tumor

Ductal hyperplasia

Atypical ductal hyperplasia

Lobular hyperplasia

Atypical lobular hyperplasia

Adenosis

Sclerosing adenosis

Adenosis tumor

Microglandular adenosis

Tubular adenosis

Cysts

Fibroadenomatoid hyperplasia

Radial sclerosing lesion (radial scar)

Ductal ectasia

Inflammatory pseudotumor

Foreign body reaction

Fat necrosis

Infarct

Infection

Hamartoma

Gynecomastia

Juvenille papillomatosis

Fibrous tumor

Diabetic mastopathy

Amyloid tumor

Pseudoangiomatous stromal hyperplasia

Asynchronous involution

Virginal hyperplasia

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Intraductal carcinoma

Lobular carcinoma in situ

Invasive ductal carcinoma

Invasive ductal carcinoma w/ predominantintraductal component

Invasive lobular carcinoma

Medullary carcinoma

Mucinous carcinoma

Invasive papillary carcinoma

Tubular carcinoma

Adenoid cystic carcinoma

Secretory (juvenille) carcinoma

Apocrine carcinoma

Carcinoma with metaplasia

Carcinoma with osteoclast-like giant cells

Cystic hypersecretory carcinoma with invasion

Carcinoma with endocrine differentiation

Glycogen-rich carcionoma

Lipid-rich (lipid-secreting) carcinoma

Invasive cribriform carcinoma

Inflammatory carcinoma

Carcinoma in pregnancy and lactation

Occult carcinoma presenting with axillary lymphnode metastases

Carcinoma in ectopic breast

Carcinoma in males

Carcinoma in children

Paget disease of nipple

Malignant cystosarcoma phyllodes

Angiosarcoma

Fibrosarcoma

Leiomyosarcoma

Chondrosarcoma

Osteosarcoma

Hemangiopericytoma

Dermatofibrosarcoma protuberans

Malignant melanoma of nipple

Squamous carcinoma of nipple

Basal cell carcinoma of nipple

Neoplasms of mammary skin

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Non-Hodgkin lymphoma

Plasmacytoma

Leukemic infiltration

Hodgkin disease

CONTEXT GROUP xxxx1 – Intended Use of CAD Output

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Presentation Required: Rendering device isexpected to present

Presentation Optional: Rendering device maypresent

Not for Presentation: Rendering device expectednot to present

CONTEXT GROUP xxxx2 – Composite Feature Relations

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Target content items are related temporally

Target content items are related spatially

Target content items are related contra-laterally

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CONTEXT GROUP xxxx3 – Scope of Feature

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Feature detected on the only image

Feature detected on only one of the images

Feature detected on multiple images

Feature detected on images from multiplemodalities

CONTEXT GROUP xxxx4 – Quantitative Temporal Difference Type

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Size

Opacity

Location

Spatial Proximity

Number of calcifications

CONTEXT GROUP xxxx4.1 – Qualitative Temporal Difference Type

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Shape

Margin

Symmetry

CONTEXT GROUP xxxx5 – Nipple Status

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Normal

Nipple Retraction

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CONTEXT GROUP xxxx6 – Non-Lesion Object Type

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Implant

Scar Tissue

Lead Pellet (BB)

Lead Marker

Bullet

J Wire

Staple

Suture

Clip

Pacemaker

Catheter

Paddle

Collimator

ID Plate

Contrast Agent

Other Marker

Unspecified

CONTEXT GROUP xxxx7 – Image Quality Finding

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Lead Marker is missing1

Lead Marker doesn’t have view and laterality2

Lead Marker doesn’t have FDA approved codes2

Lead Marker is not near the axilla2

Lead Marker is partially obscured2

Lead Marker is incorrect

Lead Marker is off film

Flash is not near edge of film2

Flash is illegible, does not fit, or is lopsided1

Flash doesn’t include patient name and additionalpatient id2

Flash doesn’t include date of examination2

Flash doesn’t include facility name and location1

Flash doesn’t include technologist identification2

Flash doesn’t include cassette/screen/detectoridentification2

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Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Flash doesn’t include mammography unitidentification2

Date sticker is missing2

Technical factors missing2

Collimation too close to breast2

Inadequate compression2

MLO Insufficient pectoral muscle2

MLO No fat is visualized posterior to fibroglandulartissues2

MLO Poor separation of deep and superficial breasttissues2

MLO Evidence of motion blur2

MLO Inframammary fold is not open2

CC Not all medial tissue visualized2

CC Nipple not centered on image2

CC Posterior nipple line does not measure within 1cm of MLO2

Insufficient implant displacement incorrect2

Image artifact

Grid artifacts

Positioning

Patient motion

Under exposed

Over exposed

No image

Detector artifacts

Artifacts other than detector artifacts

Mechanical failure

Electrical failure

Software failure

Image processing failure

Other failure

Unknown failure

1 From MQSA

2 From MQCM 1999

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CONTEXT GROUP xxxx8 – Status of Results

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Succeeded

Partially Succeeded

Failed

Not Attempted

CONTEXT GROUP xxxx9 – Types of CAD Analysis Performed

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Spatial Colocation Analysis1

Spatial Proximity Analysis2

Temporal Correlation

Image Quality Analysis

Focal Asymmetric Density

Asymmetric Breast Tissue Analysis

Breast Composition Analysis

1 Spatial Co-location Analysis is used to identify features that are the same or located in the same place.

2 Spatial Proximity Analysis is used to identify features that are related spatially, such as nipple retractionassociated with a spiculated mass.

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CONTEXT GROUP xxx10 – Types of Image Quality Assessment

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Unusable Quality renders image unusable

Usable Does not meet the quality controlstandard

Usable Meets the quality control standard

CONTEXT GROUP xxx11 – Types of Quality Control Standard

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Mammography Quality Control Manual 1999, ACR

Title 21 CFR Section 900, Mammography …

CONTEXT GROUP xxx12 – Units of Follow-up Interval

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Days

Weeks

Months

Years

CONTEXT GROUP xxx13 – Units of Linear Measurement

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

cm

mm

µm

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CONTEXT GROUP xxx14 – Units of Area Measurement

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

cm2

mm2

µm2

CONTEXT GROUP xxx15 – Units of Volume Measurement

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

cm3

mm3

µm3

CONTEXT GROUP xxx16 – Linear Measurements

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Length

Width

Depth

Diameter

Long Axis

Short Axis

Major Axis

Minor Axis

Perpendicular Axis

Diameter

Radius

Perimeter

Circumference

Diameter of circumscribed circle

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CONTEXT GROUP xxx17 – Area Measurements

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Area

Area of defined region

CONTEXT GROUP xxx18 – Volume Measurements

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Volume

Volume of sphere

Volume of ellipsoid

Volume of circumscribed sphere

Volume of bounding three dimensional region

CONTEXT GROUP xxx19 – Units of 1D, 2D and 3D Measurement

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

Include CONTEXT GROUP xxx13

Include CONTEXT GROUP xxx14

Include CONTEXT GROUP xxx15

CONTEXT GROUP xxx20 – CAD Processing Summary

Coding SchemeDesignator(0008,0102)

Code Value(0008,0100)

Code Meaning(0008,0104)

All algorithms succeeded; without findings

All algorithms succeeded; with findings

Not all algorithms succeeded; without findings

Not all algorithms succeeded; with findings

No algorithms succeeded; without findings