The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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 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 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 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 pediatric patients.

Device Description

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-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

This document is a 510(k) Summary for the Siemens Medical Solutions ACUSON S1000, S2000, S3000 Diagnostic Ultrasound System. It asserts substantial equivalence to previously cleared devices (K152369) and does not describe acceptance criteria or a study proving the device meets specific acceptance criteria in the typical sense of a novel algorithm with performance metrics.

Instead, the submission focuses on demonstrating that the modified systems have the same intended use and technological characteristics as their previously cleared counterparts, and that they conform to established medical device safety standards. Therefore, the "acceptance criteria" here refer to conformance with those safety standards and the equivalence of intended use and technological features.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present quantitative acceptance criteria or performance metrics for a novel algorithm. Instead, it asserts equivalence to previously cleared devices and compliance with general safety and performance standards.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit Conformance)
Same intended use as predicate device (K152369)	Met: Explicitly stated that "The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as the company's own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems (K152369) with regard to both intended use and technological characteristics."
Conformance to UL 60601-1 (Safety)	Met: Explicitly states "UL 60601-1 Certified" and "The system complies with the following voluntary standards: UL 60601-1".
Conformance to IEC 60601-2-37 (Diagnostic Ultrasound Safety)	Met: Explicitly states "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards."
Conformance to CSA C22.2 No. 601-1 (Safety)	Met: Explicitly states "CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment."
Conformance to AIUM/NEMA UD-3 (Thermal and Mechanical Acoustic Output)	Met: Explicitly states "AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment."
Conformance to AIUM/NEMA UD-2 (Acoustic Output Measurement)	Met: Explicitly states "AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound."
Conformance to 93/42/EEC Medical Devices Directive	Met: Explicitly states "93/42/EEC Medical Devices Directive."
Conformance to EN/IEC 60601-1, 60601-1-1, 60601-1-2 (Safety and EMC)	Met: Explicitly states various EN/IEC 60601 standards.
Biocompatibility (ISO 10993-1)	Met: Explicitly states "Tested to ISO 10993-1."
Software Release Verification	Met: "Testing was performed to verify the software release."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission is for an updated version of a previously cleared device, not a novel AI algorithm requiring a new clinical performance study with a test set of patient data. The non-clinical tests mentioned (e.g., electrical safety, biocompatibility) do not typically involve patient data test sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As noted above, this submission relies on demonstrating equivalence to an existing device rather than a clinical performance study with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new clinical performance study was conducted that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was done, as this is a 510(k) for an updated ultrasound system, not an AI-powered diagnostic aide requiring a comparative effectiveness study. The document explicitly states: "Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

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

Not applicable. This is not an AI algorithm with standalone performance being evaluated. It's a diagnostic ultrasound system.

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

Not applicable. New clinical ground truth was not established for this 510(k) submission. The safety and performance are based on compliance with standards and equivalence to the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm or a training set in this submission.

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

Not applicable. There is no mention of an AI algorithm or a training set in this submission.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

September 6, 2016

SIEMENS MEDICAL SOLUTIONS, INC. % Mr. MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET, NW BUFFALO MN 55313

Re: K162243

Trade/Device Name: ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: August 4, 2016 Received: August 10, 2016

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.

{1}------------------------------------------------

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,

Robert Oolo

Robert Ochs. Ph.D. 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)

K162243

Device Name

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound System

Indications for Use (Describe)

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.

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

ACUSON S1000, S2000, S3000 Ultrasound System 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	P
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13, 16, 18
Intraoperative(Note 9)	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
IntraoperativeNeurological	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ(Note 1)	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16, 18
Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
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	Note2,3,4,5,6,7,8,10,15
Trans-esophageal	P	P	P	P	P	P	P		BMDC	Note 4
Transrectal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Transvaginal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Transurethral	P	P	P	P	P	P	P
Intravascular	P	P	P	P	P	P	P
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10,11,14,15
Laparoscopic	P	P	P	P	P	P	P
Musculo-skeletalConventional	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 18
Musculo-skeletalSuperficial	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 18
Other (specify)Neonatal Cardiac	P	P	P	P	P	P	P		BMDC	Note 3,4,6, 10

N = new indication; P = previously cleared by FDA K152369 Additional Comments:

Note 1 i.e. breast, testes, thyroid, penis, prostate, etc. Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 9 For example: vascular, abdominal Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging Note 18 VTI

Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 13 STIC Note 15 AHP Note 17 eSie Fusion
Note 2 Ensemble tissue harmonic imaging

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510 (k) Number (if known):
Device Name:	12L4 Transducer for use with ACUSON S1000, S2000 and S3000
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
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
Small Organ(Note 1)	P	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	P	P	P	P		P	P		BMDC	Note 2,3,4,5, 7,8,10,11, 14
Laparoscopic
Musculo-skeletalConventional	P	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 K152369 Additional Comments:

Note 1 i.e.: 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

Note 10 Clarify VE vascular enhancement technology

compoundina/DTCE

Note 14 eSie™ Touch elasticity imaging

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

Note 16 Custom Tissue Imaging /FTI

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

CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System

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 K152369 Additional Comments:

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

Note 9 For example: vascular, abdominal

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

CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System

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 K152369 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal

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Intended Use:

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):
Device Name:	6-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound System

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 2,3,4,5,6, 7,8,10,11,
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,6, 7,8,10,11,14
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 K152369 Additional Comments:

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

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 2	Ensemble tissue harmonic imaging
--------	----------------------------------

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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

MC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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 2,3,4,5,6,,7,8,10,11,
IntraoperativeNote 9
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Neonatal Cephalic		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		BMDC	Note 2,3,4,5, 6, 7,8,10,11,14
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 K152369 Additional Comments:

Note 1 i.e.; breast, testes, thyroid, penis, prostate, etc Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
technology

Note 7 B&W SieScape panoramic imaging Note 9 Abdomen and Vascular

Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement

Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI

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

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

9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
Abdominal
IntraoperativeNote 9
IntraoperativeNeurological
Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ(Note 1)	P	P	P	P		P	P		BMDC	Note2,3,4,5,6,7,8,10,11,14, 16, 18
Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Adult Cephalic	P	P	P	P		P	P
Cardiac	P	P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14,15
Laparoscopic
Musculo-skeletalConventional	P	P	P	P		P	P		BMDC	Note2,3,4,5,6,7,8,10, 11,14
Musculo-skeletalSuperficial	P	P	P	P		P	P		BMDC	Note2,3,4,5,6,7,8,10, 11,14
Other (specify)

N = new indication; P = previously cleared by FDA K152369 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaqing
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial compounding
Note 15 AHP
Note 18 VTI (Virtual Touch Imaging)
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging

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

14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
Abdominal
IntraoperativeNote 9
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		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
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 K152369 Additional Comments:

Additional Comments:

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

Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular

technology

Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4

Note 6 Cadence contrast agent imaging

Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement Note 10

Note 14 eSie™ Touch elasticity imaging / FTI Note 18 Virtual Touch Imaging

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

4P1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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 2,3,4,5,7,8,10
IntraoperativeNote 9
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 2,3,4,5,6,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K152369

Additional Comments:

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

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 10 Clarify VE vascular enhancement technology

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

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

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

6C2 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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, 14, 16, 17
IntraoperativeNote 9
IntraoperativeNeurological
Pediatric	P	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	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 K152369 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology
Note 7 B&W SieScape panoramic imaging

Note 5 3-Scape real-time 3D imaging

Note 9 Abdomen and Vascular

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI

SieClear multi-view spatial compounding

Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging

Note 17 eSie Fusion

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

Note 3

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

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

4C1 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	Mode of Operation
	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
IntraoperativeNote 9
IntraoperativeNeurological
Pediatric
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 K152369 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

compounding

Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 11 Advanced Sieclear spatial

Note 16 Custom Tissue Imaging Note 18 VTI

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

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

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

6C1HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems

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
Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10, 11, 14, 16, 17,18
IntraoperativeNote 9
IntraoperativeNeurological
Pediatric
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 K152369 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology compoundinq

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 11 Advanced Sieclear spatial

Note 16 Custom Tissue Imaging Note 18 VTI

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

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

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

8C3HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems

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
IntraoperativeNote 9
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
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 K152369 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

Note 10Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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

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

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

4V1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
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 K40959 Additional Comments:

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

te 8 Power Siescape panoramic imagi
ay. Note 11 Advanced Siescape options

Note 7 B&W SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology compounding

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial

Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging Note 17 eSie Fusion

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

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

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

10V4 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
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 K# 140959 Additional Comments:

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

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

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

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

14L5 SP Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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	Note2,3,4,5,7,8,10,11
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
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 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 K# 140959 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 For example: vascular, abdominal
technology

Note 11 Advanced Sieclear spatial compounding Note 15AHP

te 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement

Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging

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

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

510 (k) Number (if known):

7CF2 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

Device Name:

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

Clinical Application	B	M	PWD	Mode of Operation			Combined(Specify)	Other(Specify)
				ColorDoppler	AmplitudeDoppler	ColorVelocityImaging
Ophthalmic
Fetal	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,10,11,13
Abdominal	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,10, 11,13
Intraoperative
Neurological
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 K# 140959 Additional Comments:

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

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 A SEPARATE PAGE IF NEEDED)

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

510 (k) Number (if known):

Device Name:

7CF1 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Mode of Operation Color Color Amplitude Combined Other PWD Clinical Application A B M CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11.13 P P P P P Note 2,3,4,5,7,8,10, BMDC Abdominal 11, 13 Intraoperative Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

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

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 A SEPARATE PAGE IF NEEDED)

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

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

9EVF4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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, 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 K# 140959 Additional Comments:

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

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 A SEPARATE PAGE IF NEEDED)

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

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

V5Ms Multiplane TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
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 K# 140959

Additional Comments:

Note 4 Tissue Equalization Technology

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

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

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

18L6 HD Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	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 K081148, K082142, K090334, K111674, K121138

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 8 Power SieScape panoramic imaging Note 11 Advanced Sieclear spatial compounding
Note 15AHP

Note 4 Tissue Equalization Technology

Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging Note 16 Custom Tissue Imaging/FTI

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

{24}------------------------------------------------

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

8V3 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	Mode of Operation								Combined(Specify)	Other(Specify)
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging
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 3,4,6
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 3,4,6

N = new indication; P = previously cleared by FDA K# 140959

Additional Comments:

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

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

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

{25}------------------------------------------------

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

4V1c Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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 7 8 10
Intraoperative		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Pediatric		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		BMDC	Note 2 3 4 5 7 8 10
Cardiac		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		BMDC	Note 2 3 4 5 7 8 1015
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10

N = new indication; P = previously cleared by FDA K#'s 140959 Additional Comments:

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

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

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

{26}------------------------------------------------

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

6L3 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic									BMDC	Note 2 3 4 5 7 8 10, 11
Fetal	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 11
Abdominal
Intraoperative Note 9	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 11
Intraoperative Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 1
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 11 15
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 11
Musculo-skeletal Superficial	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10, 11
Other (specify)

N = new indication; P = previously cleared by FDA K#'s140959 Additional Comments:

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

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology Note 15 AHP

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

EV-8C4 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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 7 8 10
Intraoperative
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 6 7 810
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K#'s 140959 Additional Comments:

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

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) Number (if known):
Device Name:

V7M TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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	Power(Amplitude)Doppler	ColorVelocityImaging	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)

P=previously cleared by the FDA under premarket notifications #K152369 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 Note 4 Tissue Equalization Technology Note 10 Clarify VE vascular enhancement technology

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patients.

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):
Device Name:	AcuNav 8F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:	The AcuNav™ Ultrasound 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

Mode of Operation Clinical Application Color Power Color Combined Other: Doppler (Amplitude) Velocity (Specify) * Harmonic A B M PWD CWD Doppler Imaging Imaging Ophthalmic Fetal Abdominal Intraoperative (Vascular) Intraoperative (Neurological) P P P P P P P Pediatric Small Organ (Specify)** Neonatal Cephalic Adult Cephalic P P P P P P P Cardiac Trans-esophageal Transrectal Transvaqinal Transurethral Intra-Luminal P P P P P P P Peripheral Vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial P P P P P Other (Intra-Cardiac) P P

P=previously cleared by the FDA K152369

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

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

AcuNav 10F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

The AcuNav™ Ultrasound 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.

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative(Vascular)
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 K152369

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+Color Doppler, 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) Summary

July 23, 2016

1. Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Shelly PearceTelephone: (650) 279-0134
2. Device Name:	Acuson S1000, S2000, S3000™ Diagnostic Ultrasound Systems
	May also be marketed as:ACUSON Oxana 1 Ultrasound SystemACUSON Oxana 2 Ultrasound SystemACUSON Oxana 3 Ultrasound SystemACUSON Oxana 2 Ultrasound Automated Breast Volume Scanner(ACUSON Oxana 2 ABVS)ACUSON Ultrasound Automated Breast Volume Scanner(ACUSON ABVS)
	Common Name: Diagnostic Ultrasound System
Classification:	Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology
	Ultrasonic Pulsed Doppler Imaging System FR # 892.1550Product Code 90-IYN
	Ultrasonic Pulsed Echo Imaging System FR # 892.1560Product Code 90-IYO
	Diagnostic Ultrasound Transducer FR # 892.1570Product Code 90-ITX
	Diagnostic Ultrasound Catheter FR # 870.1200Product Code OBJ
Manufacturing Site:	Siemens Medical Solutions USA, Inc.,2500 Millbrook Drive, Suite BMountain View, California 94043Buffalo Grove, IL 60089

The modified Acuson S1000, S2000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:

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System	510(k)
S1000	K152369
S2000	K152369
S3000	K152369

4. Device Description:

5. Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, 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 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 pediatric patients.

6. Summary of Technological Characteristics

The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as the company's own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems (K152369) with reqard to both intended use and technological characteristics. Both the subject ultrasound systems and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

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Feature / Characteristic	AcusonS1000/S2000/S3000This Submission	AcusonS1000/S2000/S3000K# 152369
Indications for Use:
■ Fetal	√	√
■ Abdominal	√	√
■ Intraoperative	√	√
■ Intraoperative neurological	-	-
■ Pediatric	√	√
■ Small Organ	√	√
■ Neonatal cephalic	√	√
■ Adult Cephalic	√	√
■ Cardiac	√	√
■ Trans-esophageal	√	√
■ Transrectal	√	√
■ Transvaginal	√	√
■ Peripheral vessel	√	√
■ 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 WaveDoppler)	√	√
■ D (Color Doppler)	√	√
■ Amplitude Doppler	√	√
■ Combined (BMDC)	√	√
Features:
Quad processing in color	√	√
■ Native™ tissue harmonicimaging	√	√
	Feature / Characteristic	AcusonS1000/S2000/S3000This Submission	AcusonS1000/S2000/S3000K# 152369
■	SieScape™ panoramicimaging	√	√
■	Color SieScape™ panoramicimaging	√	√
■	3-Scape™ real-time 3Dimaging	√	√
■	fourSight™ 4D transducertechnology	√	√
■	TEQ™ ultrasound technology	√	√
■	Cardiac Imagingphysiological signal display	√	√
■	syngo® Auto OBmeasurements	√	√
■	Advanced SieClear™ spatialcompounding	√	√
■	STIC (Fetal Heart Imaging)	√	√
■	Amnioscopic rendering	√	√
■	Cadence contrast agentimaging	√	√
■	Clarify™ vascularenhancement technology	√	√
■	eSie™ Touch elasticity imaging	√	√
■	syngo® Auto Left heart	√	√
■	syngo® Velocity VectorImaging	√	√
■	Semi Auto-segmentation (eSieCalc)	√	√
■	Custom Tissue Imaging /Speed of Sound	√	√
■	AHP	√	√
■	eSie Fusion (S3000 only)	√	√
■	VTI (S2000 & S3000 only)	√	√
Wireless		√	√
Monitor: 21" FPD		√	√
	Output Display Standard (Track 3)	√	√
	Patient Contact Materials	Tested to ISO 10993-1	Tested to ISO 10993-1
	UL 60601-1 Certified	√	√
	Indications for Use	√	√

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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, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

UL 60601-1, Safety Requirements for Medical Equipment ■
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ■
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
. AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
트 Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
ISO 10993-1 Biocompatibility ■

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 S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

9. Summary

Intended uses and other kev 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 to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Therefore it is the opinion of Siemens Medical that the S1000, S2000 and S3000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.