Siemens Medical Solutions, USA, Inc. October 15, 2020 ...2020/10/13 · U.S. Food & Drug...

U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 1 8

Silver Spring, MD 20993

www.fda.gov

Siemens Medical Solutions, USA, Inc. October 15, 2020

℅ Ms. Christine Dunbar

Senior Regulatory Affairs Specialist

22010 South East 51st Street

ISSAQUAH WA 98029

Re: K202683

Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic

Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,

ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200

Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System,

ACUSON NX3, NX3 Elite Diagnostic Ultrasound System

Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic pulsed doppler imaging system

Regulatory Class: Class II

Product Code: IYN, IYO, ITX, OBJ, LLZ, OIJ

Dated: September 11, 2020

Received: September 15, 2020

Dear Ms. Dunbar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced

above and have determined the device is substantially equivalent (for the indications for use stated in the

enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance

with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a

premarket approval application (PMA). You may, therefore, market the device, subject to the general

controls provisions of the Act. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. The general controls provisions of the Act include requirements for annual registration,

listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be

subject to additional controls. Existing major regulations affecting your device can be found in the Code of

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements

concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

has made a determination that your device complies with other requirements of the Act or any Federal

http://www.fda.gov/http://www.fda.gov/https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

K202683 – Ms. Christine Dunbar Page

2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D.

Director

Division of Radiological Health

OHT7: Office of In Vitro Diagnostics

and Radiological Health

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-productshttps://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-productshttps://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-productshttps://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-productshttps://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problemshttps://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problemshttps://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problemshttps://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problemshttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistancehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistancehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistancehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistancehttps://www.fda.gov/training-and-continuing-education/cdrh-learnhttps://www.fda.gov/training-and-continuing-education/cdrh-learnhttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dicehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dicehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dicehttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dicemailto:%[email protected]:%[email protected]

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Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: ACUSON Sequoia Diagnostic Ultrasound SystemIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

Clinical Application A B M PWD CWD ColorDopplerAmplitudeDoppler

ColorVelocityImaging

Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMDCSmall Organ(Note 1) P P P P P BMDC

Neonatal Cephalic P P P P P BMDCAdult Cephalic P P P P P BMDCCardiac P P P P P P BMDCTrans-esophagealTransrectal P P P P P BMDCTransvaginal P P P P P BMDC Volume ImagingTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC

Musculo-skeletalSuperficial P P P P P BMDC

Other (specify)N = new indication; P = previously cleared by K200707

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)________________________________________________________________________

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

____________________________________________Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k)____________________

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Device Name: 4V1 Phased Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMDCSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:





510(k)____________________

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Device Name: DAX Curved Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMCDAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







510(k)____________________

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Diagnostic Ultrasound Indications for Use Form510 (k) Number (if known):

Device Name: 5C1 Curved Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMCDAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)






____________________________________________Division Sign-Off - Office of In Vitro Diagnostic Devices510(k)____________________

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Device Name: 9C3 Curved Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMCDAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventional P P P P P BMCD

Musculo-skeletalSuperficialOther (specify)







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Device Name: 18L6 Linear Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1) P P P P P BMCD

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventional P P P P P BMCD

Musculo-skeletalSuperficial P P P P P BMCD







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1) P P P P P BMCD

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMCDLaparoscopicMusculo-skeletalConventional P P P P P BMCD








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Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMCDAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1) P P P P P BMCD

Neonatal Cephalic P P P P P BMCDAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMCDLaparoscopicMusculo-skeletalConventional P P P P P BMCD








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Device Name: 9EC4 Endocavity TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectal P P P P P BMCDTransvaginal P P P P P BMCDTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMCDSmall Organ(Note 1)Neonatal CephalicAdult Cephalic P P P P P BMCDCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMCDSmall Organ(Note 1)Neonatal Cephalic P P P P P BMCDAdult CephalicCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







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Device Name: CW2 Continuous Wave TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric PSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiac PTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMCDSmall Organ(Note 1)Neonatal Cephalic P P P P P BMCDAdult CephalicCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







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Device Name: 18H6 Linear Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ(Note 1) P P P P P BMCD

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficial P P P P P BMCD







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel PLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







of 18




Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominal P P P P P BMCDIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMCDLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







of 18



Device Name: 11M3 Curved Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMCDSmall Organ(Note 1)Neonatal Cephalic P P P P P BMCDAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







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Device Name: 9VE4 Curved Endovaginal Mechanical 3D TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

Clinical Application A B M PWD CWDColor

DopplerAmplitudeDoppler


Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ(Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginal N N N N N BMCD Volume ImagingTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)







FORM FDA 3881 (7/17) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

Device NameACUSON SC2000 Diagnostic Ultrasound System

Indications for Use (Describe)The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heai1, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. Intraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

510(k) Number (if known)K202683

FORM FDA 3881 (7/17) Page 2 of 2

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

K202683

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510 (k) Number (ifknown):

Device Name: ACUSON Freestyle™ Diagnostic Ultrasound SystemIntended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation

ClinicalApplication A B M PWD CWD

ColorDoppler

Amplitude

Doppler


Combined(Specify)(Note 2)

Other(Specify)

OphthalmicFetal

Abdominal P P PIntraoperativeIntraoperativeNeurologicalPediatric P P PSmall Organ(Note 1) P P P

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectal

TransvaginalTransurethralIntravascularPeripheral vessel P P PLaparoscopicMusculo-skeletalConventional P P P P P

Musculo-skeletalSuperficial P P P P P

Other (specify)N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:Note 1 For example: breast, testes, thyroid, penis etc.Note 2 B-mode and PWD mode or Color Doppler and PW mode




510(k)____________________

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Device Name: L8-3 Linear Array TransducerIntended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation




Other(Specify)

OphthalmicFetalAbdominal P P PIntraoperativeIntraoperativeNeurologicalPediatric P P PSmall Organ(Note 1) P P P

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P PLaparoscopicMusculo-skeletalConventional P P P

Musculo-skeletalSuperficial P P P






510(k)____________________

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Mode of Operation




Other(Specify)

OphthalmicFetal









510(k)____________________

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Mode of Operation




Other(Specify)

OphthalmicFetal

Abdominal N N NIntraoperativeIntraoperativeNeurologicalPediatric N N NSmall Organ(Note 1) N N N

Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel N N NLaparoscopicMusculo-skeletalConventional N N N

Musculo-skeletalSuperficial N N N






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Device Name: C5-2 Curvilinear Array TransducerIntended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation




Other(Specify)

OphthalmicFetal









K202683

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Diagnostic Ultrasound Indications for Use Form510 (k) Number (if known): ____________________Device Name: ACUSON S1000, S2000 and S3000 Ultrasound SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperative P P P P P P BMDC Note 2IntraoperativeNeurologicalPediatric P P P P P P BMDCSmall Organ P P P P P P BMDC Note 1Neonatal Cephalic P P P P P P BMDCAdult Cephalic P P P P P P BMDCCardiac P P P P P P BMDCTrans-esophageal P P P P P P BMDCTransrectal P P P P P BMDCTransvaginal P P P P P BMDCTransurethralIntravascularPeripheral vessel P P P P P P BMDCLaparoscopicMusculo-skeletalConventional

P P P P P P BMDC

Musculo-skeletalSuperficial

P P P P P P BMDC

Other (specify)Neonatal Cardiac

P P P P P P BMDC

N = new indication; P = previously cleared by FDA K162243


Note 1 For example: breast, testes, thyroid, penis, prostate, etc.Note 2 For example: vascular, abdominal

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)______________________________________________________________

Concurrence of Center for Devices and Radiological Health (CDRH)

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510 (k) Number (if known): ____________________Device Name: 12L4 Transducer for use with ACUSON S1000, S2000 and

S3000 Ultrasound SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as

follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMDCSmall Organ P P P P BMDC Note 1Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC

Musculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243



(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)______________________________________________________________


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510 (k) Number (if known): _________________________Device Name: CW2 Probe for use with ACUSON S1000, S2000 and S3000

Ultrasound SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal PAbdominal PIntraoperative P Note 2IntraoperativeNeurologicalPediatric PSmall Organ P Note 1Neonatal Cephalic PAdult Cephalic PCardiac PTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel PLaparoscopicMusculo-skeletalConventional P

Musculo-skeletalSuperficial P

Other (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): _________________________Device Name: CW5 Probe for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal PAbdominal PIntraoperative P Note 2IntraoperativeNeurological P

Pediatric PSmall Organ P Note 1Neonatal Cephalic PAdult Cephalic PCardiac PTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel PLaparoscopicMusculo-skeletalConventional P

Musculo-skeletalSuperficial P




(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)________________________________________________________________________


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______________________

Device Name: EC9-4 Transducer for use with ACUSON S1000, S2000 and S3000 UltrasoundSystems

Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P BMDC Note 1Neonatal Cephalic P P P P P BMDCAdult CephalicCardiacTrans-esophagealTransrectal P P P P P BMDCTransvaginal P P P P P BMDCTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ______________________Device Name: MC9-4 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P BMDC Note 1Neonatal Cephalic P P P P P BMDCAdult CephalicCardiacTrans-esophagealTransrectal P P P P P BMDCTransvaginal P P P P P BMDCTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243



(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

________________________________________________________________________Concurrence of Center for Devices and Radiological Health (CDRH)

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Diagnostic Ultrasound Indications for Use Form510 (k) Number (if known): ____________________Device Name: 9L4 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMDCSmall Organ P P P P P BMDC Note 1Neonatal Cephalic P P P P P BMDCAdult Cephalic P P P P PCardiac P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC







of 27


510 (k) Number (if known): ____________________Device Name: 14L5 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P BMDC Note 1Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC






of 27


510 (k) Number (if known): ____________________Device Name: 4P1 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal CephalicAdult Cephalic P P P P P P BMDCCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243




Concurrence of Center for Devices and Radiological Health(CDRH)

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510 (k) Number (if known): ____________________Device Name: 6C2 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMDCSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243Additional Comments:




of 27


510 (k) Number (if known): ____________________Device Name: 4C1 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P P BMDC Note 2Neonatal CephalicAdult CephalicCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243




Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510 (k) Number (if known): ____________________Device Name: 6C1 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound

SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P P BMDC Note 2Neonatal CephalicAdult CephalicCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: 8C3 HD Transducer for use with ACUSON S2000 and S3000 Ultrasound


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatric P P P P P BMDCSmall Organ P P P P P BMDC Note 2Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: 4V1 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: 10V4 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMDCSmall OrganNeonatal Cephalic P P P P P P BMDCAdult CephalicCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: 14L5 SP Transducer for use with ACUSON S1000, S2000 and S3000

Ultrasound SystemsIndications For Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application

Mode of Operation

A B M PWD CWD ColorDopplerAmplitudeDoppler


Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperative P P P P P BMDC Note 2IntraoperativeNeurologicalPediatricSmall Organ P P P P P BMDC Note 1Neonatal CephalicAdult CephalicCardiac P P P P P BMDCTransesophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC






of 27


510 (k) Number (if known): ____________________Device Name: 7CF2 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)






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510 (k) Number (if known): _________________

Device Name: 7CF1 Transducer for use with ACUSON S1000, S2000 and S3000Ultrasound SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)




(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)_____________________________________________________________________________


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510 (k) Number (if known): ________________________Device Name: 9EVF4 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal Cephalic P P P P P BMDCAdult CephalicCardiacTrans-esophagealTransrectalTransvaginal P P P P P BMDCTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243Additional Comments:




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510 (k) Number (if known): __________________Device Name: V5Ms Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophageal P P P P P P BMDCTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: 18L6 HD Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperativeIntraoperativeNeurologicalPediatricSmall Organ P P P P P BMDC Note 1Neonatal CephalicAdult CephalicCardiac P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P BMDCLaparoscopicMusculo-skeletalConventional P P P P P BMDC







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510 (k) Number (if known): _______________________Device Name: 8V3 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominalIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P BMDCSmall OrganNeonatal Cephalic P P P P P P BMDCAdult CephalicCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)Neonatal Cardiac P P P P P P BMDC

N = new indication; P = previously cleared by FDA K162243Additional Comments:




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510 (k) Number (if known): ________________________Device Name: 4V1c Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperative P P P P P P BMDC Note 2IntraoperativeNeurological P P P P P P BMDC

Pediatric P P P P P P BMDCSmall OrganNeonatal CephalicAdult Cephalic P P P P P P BMDCCardiac P P P P P P BMDCTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel P P P P P P BMDCLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)Neonatal Cardiac P P P P P P BMDC

N = new indication; P = previously cleared by FDA K162243Additional Comments:




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510 (k) Number (if known): _______________________Device Name: EV-8C4 Transducer for use with ACUSON S1000, S2000 and S3000


Mode of Operation



Combined(Specify)

Other(Specify)

OphthalmicFetal P P P P P P BMDCAbdominal P P P P P P BMDCIntraoperativePediatricSmall OrganNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginal P P P P P P BMDCTransurethralIntravascularPeripheral vesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify)N = new indication; P = previously cleared by FDA K162243





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510 (k) Number (if known): ____________________Device Name: V7MTransducer for use with ACUSON S1000, S2000 and S3000


Mode of OperationClinical Application A B M PWD CWD Color

DopplerPower

(Amplitude)Doppler


Combined(Specify) *

HarmonicImaging Other

(Specify)

OphthalmicFetalAbdominal P P P P P P P PIntraoperativeIntraoperativeNeurologicalPediatric P P P P P P P PSmall OrganNeonatal CephalicAdult CephalicCardiac P P P P P P P PTrans-esophageal P P P P P P P PTransrectalTransvaginalTransurethralIntravascularPeripheral VesselLaparoscopicMusculo-skeletal(Conventional)Musculo-skeletal(Superficial)Other (specify)



*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+ColorDoppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler,B+CWD+Power Doppler, B+Clarify VE



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__________________

Device Name: AcuNav 8F Ultrasound Catheter for use with ACUSON S1000, S2000 andS3000 Ultrasound Systems

Intended Use: The AcuNav Ultrasound Catheter is intended for intra-cardiac andintraluminal visualization of cardiac and great vessel anatomy and physiologyas well as visualization of other devices in the heart of adult and pediatricpatients.

Mode of OperationClinical Application

A B M PWD CWDColor

DopplerPower

(Amplitude)Doppler


Combined(Specify) *

Other:HarmonicImaging

OphthalmicFetalAbdominalIntraoperative(Vascular)Intraoperative(Neurological)Pediatric P P P P P P PSmall OrganNeonatal CephalicAdult CephalicCardiac P P P P P P PTrans-esophagealTransrectalTransvaginalTransurethralIntra-Luminal P P P P P P PPeripheral VesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (Intra-Cardiac) P P P P P P P



*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+ColorDoppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler,B+CWD+Power Doppler



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510 (k) Number (if known): ___________________Device Name: AcuNav 10F Ultrasound Catheter for use with ACUSON S1000, S2000

and S3000 Ultrasound SystemsIntended Use: The AcuNav Ultrasound Catheter is intended for intra-cardiac and

intraluminal visualization of cardiac and great vessel anatomy and physiologyas well as visualization of other devices in the heart of adult and pediatricpatients.

Mode of OperationClinical Application

A B M PWD CWDColor

DopplerPower

(Amplitude)Doppler


Combined(Specify) *

Other:HarmonicImaging

OphthalmicFetalAbdominalIntraoperative(Vascular)Intraoperative(Neurological)Pediatric P P P P P P PSmall OrganNeonatal CephalicAdult CephalicCardiac P P P P P P PTrans-esophagealTransrectalTransvaginalTransurethralIntra-Luminal P P P P P P PPeripheral VesselLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (Intra-Cardiac) P P P P P P P



*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+ColorDoppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler,B+CWD+Power Doppler



K202683

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Device Name: ACUSON Diagnostic Ultrasound SystemIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

Clinical Application B M PWD CWD Color DopplerAmplitude Doppler

Combined (Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperative Intraoperative NeurologicalPediatric P P P P P P BMDCSmall Organ (Note 1) P P P P P BMCDNeonatal Cephalic P P P P P BMCDAdult CephalicCardiac P P P P P P BMCDTrans-esophageal P P P P P P BMCDTransrectal P P P P P BMCDTransvaginal P P P P P BMCDTransurethralIntravascularPeripheral vessel(Note 2) P P P P P P BMCD

LaparoscopicMusculo-skeletal Conventional P P P P P BMCD

Musculo-skeletal Superficial P P P P P BMCD

Other (specify)N = new indication; P = previously cleared by FDA K180067; K180039; K187357

Note 1 For example: Breast, Thyroid, TestisNote 2 For example: Carotid, Arterial, Venous




510(k)____________________

of 14




Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetal P P P P P BMDCAbdominal P P P P P BMDCIntraoperative Intraoperative NeurologicalPediatric P P P P P BMDCSmall Organ (Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2)LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






510(k)____________________

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Device Name: 5V1 Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperative Intraoperative NeurologicalPediatric P P P P P P BMCDSmall Organ (Note 1)Neonatal CephalicAdult CephalicCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2)LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






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Device Name: 8V3 Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetalAbdominal P P P P P BMCDIntraoperative Intraoperative NeurologicalPediatric P P P P P P BMCDSmall Organ (Note 1)Neonatal CephalicAdult CephalicCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2)LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






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Device Name: 10V4 Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetalAbdominal P P P P P BMCDIntraoperative Intraoperative NeurologicalPediatric P P P P P BMCDSmall Organ (Note 1)Neonatal Cephalic P P P P P BMCDAdult CephalicCardiac P P P P P P BMCDTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2)LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






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Device Name: CW2 Continuous Wave Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperative Intraoperative NeurologicalPediatric PSmall Organ (Note 1)Neonatal CephalicAdult CephalicCardiac PTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2)LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






of 14




Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetalAbdominalIntraoperative Intraoperative NeurologicalPediatric PSmall Organ (Note 1)Neonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2) P

LaparoscopicMusculo-skeletal ConventionalMusculo-skeletal SuperficialOther (specify)






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Device Name: 10L4 Linear Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Combined (Specify)

Other(Specify)

OphthalmicFetal P P P P P BMCDAbdominal P P P P P BMCDIntraoperative Intraoperative NeurologicalPediatric P P P P P BMCDSmall Organ (Note 1) P P P P P BMCDNeonatal CephalicAdult CephalicCardiacTrans-esophagealTransrectalTransvaginalTransurethralIntravascularPeripheral vessel(Note 2) P P P P P BMCD

LaparoscopicMusculo-skeletal Conventional P P P P P BMCD

Musculo-skeletal Superficial P P P P P BMCD






of 14



Device Name: 14L5 Linear Array Transducer Intended Use: Ultrasound imaging or fluid

Siemens Medical Solutions, USA, Inc. October 15, 2020 ...2020/10/13 · U.S. Food & Drug...

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Transcript of Siemens Medical Solutions, USA, Inc. October 15, 2020 ...2020/10/13 · U.S. Food & Drug...