The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) 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 Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatic patients.

Device Description

The ACUSON S3000, S2000, S1000 Ultrasound Systems are a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

AI/ML Overview

The provided text is a 510(k) premarket notification for the SIEMENS HEALTHCARE ACUSON S2000 S2000 S1000 Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format as might be seen for an AI/ML device validating a specific diagnostic output. Instead, it justifies substantial equivalence by stating that the new device's features and characteristics are consistent with predicate devices and comply with relevant safety and performance standards.

The acceptance criteria are implicitly met by:

Identical Indications for Use: The current devices (ACUSON S3000, S2000, S1000) share the exact same stated "Indications for Use" as their predicate device (Acuson S3000, S2000, S1000 K163635) across a wide range of clinical applications. This implies that the device is expected to perform equivalently for these applications. The table from the document highlighting the identical indications for use is presented below.
Compliance with Recognized Standards: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards like AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, UL/IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, and ISO 10993-1. These standards serve as inherent acceptance criteria for the safety and foundational performance of the device.
Technological Characteristics: The document lists numerous features (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Amplitude Doppler, various imaging technologies like SieScape, 3-Scape, TEQ, etc.) that are identical to the predicate device. This implies that the performance of these features is expected to be equivalent to the cleared predicate.

Since this is a 510(k) for an ultrasound system, not an AI/ML diagnostic tool with specific quantifiable output for clinical decision-making, direct "acceptance criteria" and "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity) are not described for novel AI functions. The basis of clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those devices for their stated indications.

Table of Comparison with Predicate Device (Implicit Acceptance Criteria)

Feature / Characteristic	Acuson S3000, S2000, S1000 (New Device)	Acuson S3000,S2000, S1000 K163635 (Predicate)	QLAB K132165 (Predicate)	Device Meets Acceptance?
Indications for Use:
■ Fetal	√	√		Yes (Equivalent)
■ Abdominal	√	√		Yes (Equivalent)
■ Intraoperative abdominal and vascular	√	√		Yes (Equivalent)
■ Intraoperative neurological	--	--		Yes (Equivalent, not present)
■ Pediatric	√	√		Yes (Equivalent)
■ Small Organ	√	√		Yes (Equivalent)
■ Neonatal cephalic	√	√		Yes (Equivalent)
■ Adult Cephalic	√	√		Yes (Equivalent)
■ Cardiac	√	√		Yes (Equivalent)
■ Trans-esophageal	√	√		Yes (Equivalent)
■ Transrectal	√	√		Yes (Equivalent)
■ Transvaginal	√	√		Yes (Equivalent)
■ Peripheral vessel	√	√		Yes (Equivalent)
■ Laparoscopic	--	--		Yes (Equivalent, not present)
■ Musculo-skeletal (conventional)	√	√		Yes (Equivalent)
■ Musculo-skeletal (superficial)	√	√		Yes (Equivalent)
Center Frequencies Supported:
(Various frequencies listed, all identical)	√	√		Yes (Equivalent)
Modes:
■ B	√	√		Yes (Equivalent)
■ Parallel processing in B mode	√	√		Yes (Equivalent)
■ M	√	√		Yes (Equivalent)
■ PWD (Pulsed Wave Doppler)	√	√		Yes (Equivalent)
■ CWD (Continuous Wave Doppler)	√	√		Yes (Equivalent)
■ D (Color Doppler)	√	√		Yes (Equivalent)
■ Amplitude Doppler	√	√		Yes (Equivalent)
■ Combined (BMDC)	√	√		Yes (Equivalent)
Features:
■ Quad processing in color	√	√		Yes (Equivalent)
■ Native™ tissue harmonic imaging	√	√		Yes (Equivalent)
■ SieScape™ panoramic imaging	√	√		Yes (Equivalent)
■ Color SieScape™ panoramic imaging	√	√		Yes (Equivalent)
■ 3-Scape™ real-time 3D imaging	√	√		Yes (Equivalent)
■ fourSight™ 4D transducer technology	√	√		Yes (Equivalent)
■ TEQ™ ultrasound technology	√	√		Yes (Equivalent)
■ Cardiac Imaging physiological signal display	√	√		Yes (Equivalent)
■ syngo ® Auto OB measurements	√	√		Yes (Equivalent)
■ Advanced SieClear™ spatial compounding	√	√		Yes (Equivalent)
■ STIC (Fetal Heart Imaging)	√	√		Yes (Equivalent)
■ Amnioscopic rendering	√	√		Yes (Equivalent)
■ Cadence contrast agent imaging	√	√		Yes (Equivalent)
■ Contrast Dynamics	√	(blank)	√	Yes (Equivalent to QLAB predicate)
■ Clarify™ vascular enhancement technology	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ eSie™ Touch elasticity imaging	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ syngo ® Auto Left heart	Tested to ISO 10993-1	√	(blank)	Yes (Equivalent to K163635 predicate)
■ syngo ® Velocity Vector Imaging	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ Semi Auto-segmentation (eSie Calc)	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ Custom Tissue Imaging / Speed of Sound	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ VTI (S2000, S3000)	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ VTIQ (S2000, S3000)	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ VTQ (S2000, S3000)	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ AHP	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ Monitor: 19" FPD	√	√	(blank)	Yes (Equivalent to K163635 predicate)
■ eSie Fusion	√	√	(blank)	Yes (Equivalent to K163635 predicate)
Output Display Standard (Track 3)	√	√	(blank)	Yes (Equivalent to K163635 predicate)
Patient Contact Materials	Tested to ISO 10993-1	Tested to ISO 10993-1	(blank)	Yes (Equivalent)
UL 60601-1 Certified	√	√	(blank)	Yes (Equivalent)

2. Sample size used for the test set and the data provenance

The document states: "Since the ACUSON S3000, S2000, S1000 Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required." This indicates that no specific test set or clinical study was conducted for this 510(k) submission to demonstrate performance on new data. The primary method of demonstrating substantial equivalence was through comparison with predicate devices and compliance with non-clinical performance standards.

Therefore, information on sample size, country of origin, or retrospective/prospective nature of a test set is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no specific clinical test set was used for this submission, there is no mention of experts establishing ground truth for a test set. The device relies on the established safety and efficacy of its predicate devices and compliance with engineering standards.

4. Adjudication method for the test set

Not applicable, as no dedicated test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not conducted or referenced, as clinical data was deemed not required due to substantial equivalence claims to existing devices with the same technology and principles. Therefore, there's no reported effect size of how human readers improve with AI vs. without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not an AI/ML product in the context of "algorithm only" performance. It is a diagnostic ultrasound system. Its performance evaluation is based on meeting safety and performance standards and being substantially equivalent to existing ultrasound systems, not on a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)

No specific "ground truth" as typically defined for AI/ML diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) was used or required for this 510(k) submission. The substantial equivalence argument relies on the inherent capabilities and safety profiles of the technological principles and features that are identical to previously cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2017

SIEMENS HEALTHCARE C/O Mr. MARK JOB Responsible Third Party Official 1394 25TH STREET, NW BUFFALO MN 55313

Re: K172162

Trade/Device Name: Acuson S2000 S2000 S1000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: July 10, 2017 Received: July 18, 2017

Dear Mr. Job:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara For

Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172162

Device Name

ACUSON S3000™, S2000™, S1000™ Diagnostic Ultrasound System

Indications for Use (Describe)

The Transducer Indications for Use are on the attached pages.

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

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 complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services. Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

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1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: ACUSON S3000, S2000, S1000 Diagnostic Ultrasound Systems

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic		P	P	P	P	P	P
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 12
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,13, 16,18,20
Intraoperative(Note 9)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6, 7,8,10, 11
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6, 7,8,10,11,14, 16,18,19,20
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,15
Trans-esophageal		P	P	P	P	P	P		BMDC	Note 4
Transrectal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6, 7,8,10,11,14
Transvaginal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Other (specify)		P	P	P	P	P	P		BMDC	Note 3,4,10,17

N = new indication; P = previously cleared by K162243; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)

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

Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
For example: vascular, abdominal Note 9
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging / FTI Note 14
Note 16 Custom Tissue Imaging VTI
Note 18
Note 6 Cadence contrast agent imaging Power SieScape panoramic imaging Note 8 Note 10 Clarify VE technology Note 13 STIC Note 15 AHP
Ensemble tissue harmonic imaqing

Tissue Equalization Technology

Note 17 eSie Fusion
Note 19 VTIQ

Note 2

Note 4

Note 20 VTQ

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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510 (k) Number (if known):

Device Name:			CW2 Probe
Intended Use:									Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

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

Additional Comments:

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

Note 9 For example: vascular, abdominal

(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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510 (k) Number (if known):

Device Name:			CW5 Probe
Intended Use:							Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological					P
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

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

Additional Comments:

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

Note 9 For example: vascular, abdominal

(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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510 (k) Number (if known):

Device Name:Intended Use:	EC9-4 Curved Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,17
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	P	P	P	P		P	P		BMDC	Note 2,3,4,5, 6, 7,8,10,11,14
Transvaginal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie™ Fusion

(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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510 (k) Number (if known):

Device Name:	9L4 Linear Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal		P	P	P		P	P		BMDC	Note 6,18,20 – any others?
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,6, 7,8,10, 11
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14,16,18,19,20
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic		P	P	P		P	P
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5, 7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
Other (specify)

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

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
Note 19 VTIQ

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

Note 2

Note 4

Note 6

Note 8

Note 15 AHP

Note 18 VTI

Note 20 VTQ

Note 11 Advanced Sieclear

Ensemble tissue harmonic imaging

Power SieScape panoramic imaging

Tissue Equalization Technology

Cadence contrast agent imaging

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

Division Sign-Off - Office of In Vitro Diagnostic Devices

{8}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

14L5BV Multi-D Array Transducer for use on S2000

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K081148

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

(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

{9}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:		4P1 Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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510(k)

{10}------------------------------------------------

510 (k) Number (if known):

Device Name:	6C2 Curved Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16, 17
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Tissue Equalization Technology Note 4

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

Power SieScape panoramic imaging Note 8

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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

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{11}------------------------------------------------

510 (k) Number (if known):

Device Name:	4C1 Curved Array Transducer
Intended Use:									Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,18,19,20
Abdominal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10, 11, 14, 16, 17
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P			Note 6 - others?
Small Organ	P	P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Power SieScape panoramic imaging Note 8
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 20 VTQ
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 19 VTIQ

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

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{12}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	6C1HD Curved Array Transducer HDUltrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10,11,14,16,17,18,19,20
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 6 – others?
Small Organ		P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging

Note 20 VTQ

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

eSie Fusion Note 17 Note 19 VTIQ

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Note 18 VTI

{13}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	8C3HD Curved Array Transducer for use with ACUSON S3000Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K#121138, K162243

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

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

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Division Sign-Off - Office of In Vitro Diagnostic Devices

{14}------------------------------------------------

510 (k) Number (if known):

Device Name:	4V1 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
								Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,14,16,17,18,19,20
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
Note 7 B&W SieScape panoramic imaqinq
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 19 VTIQ
Note 3 SieClear multi view spatial compounding
3-Scape real-time 3D imaging Note 5
Power SieScape panoramic imaqing Note 8
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 20 VTQ

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

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{15}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	10V4 Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC	Note 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

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510(k)
--------	--

{16}------------------------------------------------

510 (k) Number (if known):

Device Name:	14L5 SP Linear Array Transducer
Indications For Use:	Diagnostic imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 9)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

For example: vascular, abdominal Note 9

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

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

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510(k)

Note 15 AHP

Note 16 Custom Tissue Imaging

Note 15 AHP

Note 16 Custom Tissue Imaging

{17}------------------------------------------------

510 (k) Number (if known):

Device Name:	7CF2 Curved array mechanical 3D transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,13
Abdominal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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

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{18}------------------------------------------------

510 (k) Number (if known):

Device Name:

9EVF4 Curved Array Transducer

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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

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{19}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	V5Ms Multiplane TEE TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P		BMDC	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Tissue Equalization Technology Note 4

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510(k)________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{20}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	18L6 HD Linear Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Other (specify)

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

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaqinq

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

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

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Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k)

Note 15 AHP

Note 16 Custom Tissue Imaging

{21}------------------------------------------------

510 (k) Number (if known):

8V3 Phased Array Transducer

Device Name: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 3,4

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaqing

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

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{22}------------------------------------------------

510 (k) Number (if known):

4V1c Phased Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color VelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
IntraoperativeNeurological		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Pediatric		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Cardiac		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 1015
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaqinq

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

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

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{23}------------------------------------------------

510 (k) Number (if known):

Device Name:	EV8C4 Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 6 7 810
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaqing

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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510 (k) Number (if known):

Device Name:	V7M TEE Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify) *	HarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	Note 4
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P	Note 4
Small Organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	Note 4
Trans-esophageal	P	P	P	P	P	P	P	P	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

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

Additional Comments:

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

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER, B+CLARIFY VE

Note 2 Ensemble tissue harmonic imaging

Tissue Equalization Technology Note 4
Note 10 Clarify VE vascular enhancement technology

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510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter

›uCatheter is 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.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative
Intraoperative(Neurological)
Pediatric	P	P	P	P	P	P	P		P
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P		P

P=Previously cleared by the FDA K162243

Additional Comments:

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

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510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter

uCatheter is 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.

Clinical Application	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Combined (Specify) *
Ophtalmic
Fetal
Abdominal
Intraoperative
Intraoperative(Neurological)
Pediatric	P	P	P	P	P	P	P
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P

P=Previously cleared by the FDA K162243

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

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510 (k) Number (if known): Device Name: Intended Use:

MC9-4 Transducer

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

Clinical Application	A	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11
Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ (note1)	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,10,11,14
Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,10,11,14
Transvaginal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

i.e.: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 3 SieClear multi-view spatial compounding

Note 5 Siescape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE Vascular enhancement technology

Note 14 eSie Touch elasticity imaging/FTI

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

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510 (k) Number (if known): Device Name: Intended Use:

14L5 Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ (note1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,10,11,14,16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,6,7,8,10,11,14
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.

SieClear multi-view spatial compounding Note 3

Siescape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaqinq

Note 10 Clarify VE Vascular enhancement technology

Note 14 eSie Touch elasticity imaging/FTI

Note 2 For example: vascular, abdominal
Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

Note 8 Power SieScape panoramic imaqing

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

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510(k) Summary Prepared April 24, 2017

1. Sponsor:	Siemens Medical Solutions USA, Inc.,
Contact Person:	Ultrasound Division685 East Middlefield RoadMountain View, California 94043Shelly PearceTelephone: (650)279-0134
2. Device Name:	ACUSON S3000™, S2000™, S1000™ Diagnostic Ultrasound Systems
Common Name:	Diagnostic Ultrasound System
Classification:
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYM
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYC
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Ultrasound Catheter	FR # 870.1200	Product Code OBJ

3. Leqally Marketed Predicate Devices

The modified ACUSON S3000™, S2000™, S1000™, S1000™ Ultrasound Systems is substantially equivalent to the company's own S3000 Ultrasound System (K163635) and Philips QLAB (K0132165).

4. Device Description:

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5. Intended Use

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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 Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is 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.

Feature / Characteristic	AcusonS3000,S2000,S1000	AcusonS3000,S2000, S1000K163635	QLABK132165
Indications for Use:
■ Fetal	√	√
■ Abdominal	√	√
■ Intraoperative abdominal andvascular	√	√
■ Intraoperative neurological	--	--
■ Pediatric	√	√
■ Small Organ	√	√
■ Neonatal cephalic	√	√
■ Adult Cephalic	√	√
■ Cardiac	√	√
■ Trans-esophageal	√	√
■ Transrectal	√	√
■ Transvaginal	√	√
■ Peripheral vessel	√	√
	Feature / Characteristic	AcusonS3000,S2000,S1000	AcusonS3000,S2000, S1000K163635	QLABK132165
■	Laparoscopic	--	--
■	Musculo-skeletal (conventional)	√	√
■	Musculo-skeletal (superficial)	√	√
	Center Frequencies Supported:
■	2.0 MHz	√	√
■	3.0 MHz	√	√
■	3.2 MHz	√	√
■	3.3 MHz	√	√
■	4.2 MHz	√	√
■	4.4 MHz	√	√
■	4.8 MHz	√	√
■	5.0 MHz	√	√
■	5.2 MHz	√	√
■	6.0 MHz	√	√
■	6.5 MHz	√	√
■	6.9 MHz	√	√
■	9.5 MHz	√	√
■	10.0 MHz	√	√
	Modes:
■	B	√	√
■	Parallel processing in B mode	√	√
■	M	√	√
■	PWD (Pulsed Wave Doppler)	√	√
■	CWD (Continuous Wave Doppler)	√	√
■	D (Color Doppler)	√	√
■	Amplitude Doppler	√	√
■	Combined (BMDC)	√	√
	Features:
■	Quad processing in color	√	√
■	Native™ tissue harmonic imaging	√	√
■	SieScape™ panoramic imaging	√	√
■	Color SieScape™ panoramic imaging	√	√
■	3-Scape™ real-time 3D imaging	√	√
■	fourSight™ 4D transducertechnology	√	√
■	TEQ™ ultrasound technology	√	√
■	Cardiac Imagingphysiological signal display	√	√
■	syngo ® Auto OB measurements	√	√
■	Advanced SieClear™ spatialcompounding	√	√
■	STIC (Fetal Heart Imaging)	√	√
■	Amnioscopic rendering	√	√
■	Cadence contrast agent imaging	√	√
Feature / Characteristic	AcusonS3000,S2000,S1000	AcusonS3000,S2000, S1000K163635	QLABK132165
■ Contrast Dynamics	√		√
■ Clarify™ vascular enhancementtechnology	√	√
■ eSie™ Touch elasticity imaging	√	√
■ syngo ® Auto Left heart	Tested to ISO10993-1	√
■ syngo ® Velocity Vector Imaging	√	√
■ Semi Auto-segmentation (eSieCalc)	√	√
■ Custom Tissue Imaging / Speed ofSound	√	√
■ VTI (S2000, S3000)	√	√
■ VTIQ (S2000, S3000)	√	√
■ VTQ (S2000, S3000)	√	√
■ AHP	√	√
■ Monitor: 19" FPD	√	√
■ eSie Fusion	√	√
Output Display Standard (Track 3)	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√
Indications for Use		√

6. Summary of Technological Characteristics - New Device Compared to Predicate

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Siemens Medical Solutions USA, Ultrasound Division ACUSON S3000™, S2000™, S1000™ Ultrasound Systems 510(k)

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Siemens Medical Solutions USA, Ultrasound Division ACUSON S3000™, S2000™, S1000™ Ultrasound Systems 510(k)

7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
트 IEC 62359, Test methods for the determination of thermal and mechanical indices
Safety and EMC Requirements for Medical Equipment I
- o UL/IEC 60601-1
- o AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012
- o IEC 60601-1-2
- o IEC 60601-2-18
- o IEC 60601-2-37
ISO 10993-1 Biocompatibility I

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Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the ACUSON S3000, S2000, S1000 Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.

9. Summarv

Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON S3000. S2000. S1000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Image /page/33/Picture/6 description: The image shows the word "SIEMENS" in a bold, teal-colored font. The letters are all capitalized and evenly spaced. The background is plain white, which makes the word stand out.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.