The S2000 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system aiso provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Description

The Acuson S2000™ Ultrasound System is a new 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, 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 is a 510(k) premarket notification for the Siemens Acuson S2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and supported transducers. As such, it does not contain the type of performance study data and acceptance criteria typically found for AI/ML-driven devices.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert qualifications, and comparative effectiveness studies are not present in this document.

Summary of Available Information:

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

This document is a 510(k) submission for a diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and lists the safety standards it meets (e.g., UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37, IEC 61157, ISO 10993).

It does not include specific performance acceptance criteria or reported device performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). The "performance" assessment is based on demonstrating that the device functions as intended and is safe, aligning with its predicate devices.

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 document does not describe a performance study with a test set.

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. This document does not describe a performance study with a test set requiring ground truth establishment by experts.

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

Not applicable. This document does not describe a performance study with a test set requiring 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. This document does not describe a multi-reader, multi-case comparative effectiveness study or involve AI assistance for human readers. It focuses on the capabilities of the ultrasound system itself.

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

Not applicable. This device is a diagnostic ultrasound system, not an algorithm being tested in a standalone fashion. Its performance is inherent in its operation as a medical imaging device.

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

Not applicable. There is no performance study where ground truth would be established for the device's diagnostic capabilities in this 510(k). The regulatory submission is for the device's safety and effectiveness based on its intended use and comparison to legally marketed predicate devices, not for a novel diagnostic algorithm requiring independent ground truth validation.

8. The sample size for the training set:

Not applicable. This document does not pertain to an AI/ML algorithm that would have a training set.

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

Not applicable. This document does not pertain to an AI/ML algorithm that would have a training set.

Summary

{0}------------------------------------------------

NOV 1 3 2007

510(K) SUMMARY

S2000 Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:

Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043

Contact Person:

Shelly Pearce Requlatory Affairs

Phone: (650) 694-5988 FAX: (650) 943-7053

Date Prepared:

September 4, 2007

2. Proprietary Name:

Acuson S2000™ Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550
Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYC
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

3. Predicate Device:

K063803, 11/22/2006, Acuson Antares Diagnostic Ultrasound System K063085, 11/14/2006, Acuson Sequoia Diagnostic Ultrasound System K032620, 10/10/2003, GE Voluson 730 Ultrasound System

4. Device Description:

The S2000, has been designed to meet the following product safety standards:

. UL 60601-1, Safety Requirements for Medical Equipment
. 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 트 Output Indices on Diagnostic Ultrasound Equipment
트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound

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

93/42/EEC Medical Devices Directive 를
트 Safety and EMC Requirements for Medical Equipment
- EN 60601-1 트
- 이 EN 60601-1-1
- EN 60601-1-2
- . EN 60601-2-37
트 IEC 61157 Declaration of Acoustic Power
ISO 10993 Biocompatibility 트

ട. Intended Uses:

The system aiso provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Technological Comparison to Predicate Device: 6.

The S2000 is substantially equivalent to the Acuson Antares, cleared via K063803, the Acuson Sequoia, cleared via K063085, and the GE Voluson, cleared via K032620. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the figure. The text is in all caps and is smaller than the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2007

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K072786

Trade/Device Name: Acuson S2000™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 29, 2007 Received: October 1, 2007

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

CW2 Probe CW5 Probe 9EC4 Curved Array 9L4 Linear Array 14L5 Multi-D Array

4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array 10V4 Phased Array

{3}------------------------------------------------

14L5 SP Linear Array	V5Ms Multiplane TEE
7CF2 Curved Array	17L5HDS Linear Array
9EVF4 Curved Array	8V3 Phased Array

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

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

{4}------------------------------------------------

Page 2 – Mr. Job

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Vonn M. Whing

Nancy C. Brogdon ਨਾ Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

Siemens Medical Solutions USA, Inc. Ultrasound Division

Page 1 of 1

510(k) Number (if known): K072786

Device Name:

Acuson S2000™ Diagnostic Ultrasound System

Indications for Use:

The S2000™ 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Prescription Use __ XX_ (Part 21 CFR 801 Subpart D) OR

Over-the-Counter-Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

thry M. Why

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{6}------------------------------------------------

ACUSON S2000™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: ACUSON S2000 Ultrasound System

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

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11, 13
Abdominal	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11, 13
Intraoperative(Note 9)	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11, 14
IntraoperativeNeurological	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11, 14
Pediatric	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11
Small Organ(Note 1)	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cephalic	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10
Cardiac	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal	N	N	N	N	N	N	N	BMDC
Transrectal	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11,14
Transvaginal	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel	N	N	N	N	N	N	N	BMDC	Note2,3,4,5,6,7,8,10, 11,14
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11,14
Musculo-skeletalSuperficial	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,10, 11,14
Other (specify)	N	N	N	N	N	N	N	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

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

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

Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 9 For example: vascular, abdominal

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear multi-view spatial compouriding

. 4. 1. 1

STIC Note 13
Note 14 eSie™ Touch elasticity imaging/FTI

Lorine Mintez

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.10 Diagnostic Ultrasound Indications for Use Form

{7}------------------------------------------------

ACUSON S2000™ Diagnostic Ultrasound System

510(k) Submission

510 (k) Number (if known):

Device Name: Intended Use: CW2 Probe for use with ACUSON 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					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 K# 063803; E = added under Appendix E

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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Amai Th. Wh

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

510 (k) Number (if known):

Device Name:

CW5 Probe for use with ACUSON S2000

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 K# 063803; E = added under Appendix E

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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Lori Khan
(Division Sign Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

ACUSON S2000" Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

9EC4 Curved Array Transducer for use with ACUSON S2000

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	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	Note2,3,4,5,6,7,8,10, 11
IntraoperativeAbdominal
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 2,3,4,5,7,8,10,11,14
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 K# 063803; E = added under Appendix E

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

Tissue Equalization Technology Note 4
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

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

Aymm Whay
(Division Sign Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

ACUSON S2000™ Diagnostic Ultrasound System
510(k) Submission

510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Devicc Name: Intended Use:

9L4 Linear Array Transducer for use with ACUSON 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		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
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
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
Musculo-skeletalSuperficial		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 K# 063085; E = added under Appendix E

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
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 multi-view spatial compounding
eSie™ Touch elasticity imaging/FTI Note 14

fruch why

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: . 14L5 Multi-D Array Transducer for use with ACUSON 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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
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 K# 063085; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
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
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear multi-view spatial compounding

. 1

Note 14 eSie™ Touch elasticity imaging/FTI
loun M. Whz
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4P1 Phased Array Transducer for use with ACUSON 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		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
IntraoperativeAbdominal
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 K# 063803; E = added under Appendix E

Additional Comments:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Aonald M. Whiz

(DIV Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

. .

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

510 (k) Number (if known):

Device Name:

Intended Use:

6C2 Curved Array Transducer for use with ACUSON 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	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
IntraoperativeAbdominal
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 K# 063085; E = added under Appendix E

Additional Comments:

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 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

Advanced Sieclear multi-view spatial compounding Note 11

Arith Wh

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

510 (k) Number (if known):

Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000

Ultrasound imaging or fuid 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	Note2,3,4,5,6,7,8,10, 11
IntraoperativeAbdominal
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 K# 063085; E = added under Appendix E

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 11 Advanced Sieclear multi-view spatial compounding

(Division Sign-Off)

Division of Reproductive, Abdominal an Radiologic 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer for use with ACUSON 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		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,
IntraoperativeAbdominal
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 K# 063085; E = added under Appendix E

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
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number KD72786

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510 (k) Number (if known):

Device Name:

Intended Use:

10V4 Phased Array Transducer for use with ACUSON 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		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
IntraoperativeAbdominal
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		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# 063085; E = added under Appendix E

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

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K073278

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510 (k) Number (if known):

Device Name:

Indications For Use:

14L5 SP Linear Array Transducer for use with ACUSON S2000 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
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
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	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E

ਕ

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear multi-view spatial compounding Note 11
Note 14 eSie™ Touch elasticity imaging/FTI

(Division Sign-Off)

eproductive, Abdominal and Radiologic 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

ACUSON S2000" Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

7CF2 Curved array mechanical 3D transducer for use with ACUSON 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		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
IntraoperativeAbdominal
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 K# 063803; E = added under Appendix E

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 Note 8
Power SieScape panoramic imaging Note 10
Clarify VE vascular enhancement technology Note 11 Advanced Sieclear multi-view spatial compounding
Note 13 STIC

Loui K. Whig
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510 (k) Number (if known):

Device Name: Intended Use: 9EVF4 Curved Array Transducer for use with ACUSON 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		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal
IntraoperativeAbdominal
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# 063803; E = added under Appendix E

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
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding

Lory 2. Why
(Division Sign-Off)

vision of Reproductive, Abdominal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510 (k) Number (if known):

Device Name: Intended Use:

V5Ms Multiplane TEE Transducer for use with ACUSON 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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P		BMDC
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E

Additional Comments: n/a

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

tony h. Whx

Division of Reproductive. Abdominal a Radiological Devices 510(k) Number

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

KC72786

ACUSON S2000" Diagnostic Ultrasound Syste 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

17L5HDS Linear Array Transducer for use with ACUSON 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
IntraoperativeAbdominal
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
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	P	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 K# 063085; E = added under Appendix E

Additional Comments:

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

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

Note 11 Advanced Sieclear multi-view spatial compounding

Note 14 eSie™ Touch elasticity imaging/FT1

loyne K. Witz

oductive. Abdominal and Divisio Radiolo 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K072786

510 (k) Number (if known):

Device Name:

Intended Use:

8V3 Phased Array Transducer for use with ACUSON 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	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal
IntraoperativeAbdominal
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 3,4,6
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac	P	P	P	P	P	P	P		BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E

Additional Comments:

Ensemble tissue harmonic imaging Note 2

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

Division Sign-Off

ductive. Abdorninal and Radiological Devices 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.