The S2000 and S3000 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), musculoskeletal (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.

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 intended for 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.

Virtual Touch Imaging and eSie Touch Elastography provide qualization of relative stiffness between tissues with different elastic properties.

Device Description

The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an 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. It is substantially equivalent to the S2000 (K111674) and S3000 system (K121138) which are legally marketed devices.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens Medical Solutions Acuson S2000 and S3000 Diagnostic Ultrasound Systems:

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria or conducting extensive clinical trials for new applications. As such, the information provided is geared towards proving that the new device performs as well as or similarly to existing cleared devices.

Based on the provided text, the key "device" being discussed is the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, including various transducers and software features like Virtual Touch Imaging (VTI) and eSie Touch Elastography.

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document does not explicitly state quantitative acceptance criteria in the way one might expect for a new performance claim (e.g., "sensitivity must be >X%"). Instead, the primary "acceptance criterion" demonstrated throughout this 510(k) submission is substantial equivalence to predicate devices. The "reported device performance" is essentially that the new device operates similarly and safely.

The document highlights the features and indications for use as being equivalent to previously cleared devices.

Acceptance Criterion (Implicit: Substantial Equivalence via Feature/Performance Comparison)	Reported Device Performance (as demonstrated by comparison)
Indications for Use (General Ultrasound Applications)	Identical to predicate devices (Acuson S2000 K111674, S3000 K121138, Acuson Antares K063138, Acuson S3000 K122825). Covers Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Technological Characteristics (Modes, Frequencies, Features)	Confirmed to be consistent with or improved from predicate devices. Specifically, modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) and a range of center frequencies (2.0 MHz to 10.0 MHz) are available, matching or expanding on predicates. Features like Native™ tissue harmonic imaging, SieScape™ panoramic imaging, 3-Scape™ real-time 3D, TEQ™ ultrasound technology, etc., are also present.
Safety (Acoustic Output, Biocompatibility, Electrical, Thermal, Mechanical, EMC)	Device evaluated and found to conform with applicable medical device safety standards (e.g., UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, UD-2, 93/42/EEC, EN/IEC 60601-1-1/2, IEC 1157, ISO 10993-1). Cleared patient contact materials, electrical, and mechanical safety are unchanged.
Performance for Elastography (Virtual Touch Imaging - VTI)	"Additional testing was performed to compare EI to VTI by validating intra-operator and inter-operator reproducibility of VTI using EI as a benchmark. Visual comparison of phantom images generated with EI and VTI demonstrate more consistent contrast to noise ratio and clearer inclusion visualization with VTI than with EI." (This implies a qualitative improvement, not a quantitative acceptance metric.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of cases or patients. The document refers to "phantom images" for the elastography comparison.
Data Provenance: Not specified for the phantom study (e.g., no country of origin, no mention of retrospective or prospective data collection from human subjects). It's a non-clinical test.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable, as expert involvement for establishing ground truth on a test set (clinical data) is not mentioned. The primary comparison for elastography was qualitative visual comparison of phantom images.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No mention of multiple readers or an adjudication process for clinical ground truth. The comparison for elastography (EI vs VTI) was described as "visual comparison of phantom images."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No. The document states: "The S2000 and S3000 use the same technology and principles as existing devices, clinical data is not required." This explicitly indicates that a comparative effectiveness study involving human readers and clinical data was not performed or submitted for this 510(k).
Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done?: Not in the typical sense of a quantitative diagnostic system evaluated against clinical ground truth. The "additional testing" for Virtual Touch Imaging (VTI) involved a "visual comparison of phantom images generated with EI and VTI." This is a qualitative assessment of the image quality and reproducibility on a phantom, not a standalone diagnostic performance metric on a clinical dataset. The system itself is a diagnostic ultrasound, implying direct human operation rather than a standalone algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used

Type of Ground Truth:
- For the overall device, the implicit ground truth is substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices known to be safe and effective.
- For the specific feature of Virtual Touch Imaging (VTI), the "ground truth" for comparison was the Established Imaging (EI) technique on phantoms, and the assessment was "visual comparison" for "more consistent contrast to noise ratio and clearer inclusion visualization." This isn't a pathological or outcome-based ground truth, but a comparative image quality assessment on a controlled phantom.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes a medical device undergoing premarket notification (510(k)), not an AI/ML algorithm development with distinct training and test sets as typically understood. The device is an ultrasound system with advanced imaging features.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable. See point 8.

Summary

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

510(k) Summary Prepared March 12, 2013

JUN 6 2013

Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043

Contact Person:	Shelly PearceTelephone:Fax:	(650) 694-5988(650) 694-5580
-----------------	-------------------------------------	----------------------------------

1. Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems
- Common Name: Diagnostic Ultrasound System

Classification:

Regulatory Class: ll Review Category: Tier II Classification Panel: Radiology

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

3. Legally Marketed Predicate Devices

The Acuson S2000 and S3000 Ultrasound Systems are substantially equivalent to the company's own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329)

4. Device Description:

5. Intended Use

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

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, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adiunctively 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 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.

Virtual Touch Imaging and eSie Touch Elastography provide qualitation of relative stiffness between tissues with different elastic properties.

	Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	AcusonAntaresK063138
	Indications for Use:
■	Fetal	√	√	√	√	√
■	Abdominal	√	√	√	√	√
■	Intraoperative abdominal andvascular	√	√	√	√	√
	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	√	√	√	√	√
Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	AcusonAntaresK063138
■ 3.0 MHz	√	√	√	√	√
■ 3.2 MHz	√	√	√	√	√
■ 3.3 MHz	√	√	√	√	√
■ 4.2 MHz	√	√	√	√	√
■ 4.4 MHz	√	√	√	√	√
■ 4.8 MHz	√	√	√	√	√
■ 5.0 MHz	√	√	√	√	√
■ 5.2 MHz	√	√	√	√	√
■ 6.0 MHz	√	√	√	√	√
■ 6.5 MHz	√	√	√	√	√
■ 6.9 MHz	√	√	√	√	√
■ 9.5 MHz	√	√	√	√	√
■ 10.0 MHz	√	√	√	√	√
Modes:
■ B	√	√	√	√	√
■ Parallel processing in B mode	√	√	√	√	√
■ M	√	√	√	√	√
■ PWD (Pulsed Wave Doppler)	√	√	√	√	√
■ CWD (Continuous Wave Doppler)	√	√	√	√	√
■ D (Color Doppler)	√	√	√	√	√
■ Amplitude Doppler	√	√	√	√	√
■ Combined (BMDC)	√	√	√	√	√
Features:
Quad processing in color	√	√	√	√	√
■ Native™ tissue harmonic imaging	√	√	√	√	√
■ SieScape™ panoramic imaging	√	√	√	√	√
■ Color SieScape™ panoramicimaging	√	√	√	√	√
■ 3-Scape™ real-time 3D imaging	√	√	√	√	√
■ fourSight™ 4D transducertechnology	√	√	√	√	√
■ TEQ™ ultrasound technology	√	√	√	√	√
■ Extend imaging technology	√	√	√	√	√
■ Cardiac Imagingphysiological signal display	√	√	√	√	√
syngo ® Auto OB measurements	√	√	√	√	√
■ Advanced SieClear™ spatialcompounding	√	√	√	√	√
■ STIC (Fetal Heart Imaging)	√	√	√	√	√
■ Amnioscopic rendering	√	√	√	√	√
■ Cadence contrast agent imaging	√	√	√	√	√
■ Clarify™ vascular enhancementtechnology	√	√	√	√	√
■ eSie™ Touch elasticity imaging	√	√	√	√	√
■ eSie Fusion		√	√
Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K122825	AcusonS2000K111674	AcusonAntaresK063138
• syngo ® Velocity Vector Imaging	√	√	√	√	√
• Semi Auto-segmentation (eSieCalc)	√	√	√	√	√
• Custom Tissue Imaging / Speed ofSound	√	√	√	√	√
• AHP	√	√	√	√	√
• VTI	√	√	√	√	√
• 18L6HD Transducer	√	√	√	√
• 6C1HD Transducer		√
• 8C3HD Transducer		√	√
• Monitor: FPD	√	√	√	√	√
Output Display Standard (Track 3)	√	√	√	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√	√	√	√

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

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

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

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

The devices have 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 비
AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AIUM/NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive .
Safety and EMC Requirements for Medical Equipment
- =
- EN/IEC 60601-1-1 .
- . EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility .

Cleared patient contact materials, electrical and mechanical safety are unchanged.

Additional testing was performed to compare El to VTI by validating intra-operator and interoperator reproducibility of VTI using El as a benchmark. Visual comparison of phantom images generated with El and VTI demonstrate more consistent contrast to noise ratio and clearer inclusion visualization with VTI than with EI.

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

The S2000 and S3000 use the same technology and principles as existing devices, clinical data is not required.

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

9. Summary

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or wings extending upwards.

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

June.6, 2013

Siemens Medical Solutions USA. Inc. % Ms. Shelly Pearce Regulatory Affairs 685 East Middlefield Road MOUNTAIN VIEW CA 94043

Re: K130739

Trade/Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX, OBJ Dated: March 14, 2013 Received: March 21, 2013

Dear Ms. Pearce:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

CW2 9L4 Linear Array 6C2 Curved Array 4V1 Phased Array 7CF2 Curved Array 8V3 Phased Array EV8C4 V7M TEE

CW5 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4VIc Phased Array 8C3HD Curved Array AcuNav 8F

EC9-4 Curved Array 4P1 Phased Array 6C1HD Curved Array 14L5 SP Linear Array V5Ms Multiplane TEE 613 18L6 HD Linear Array AcuNav 10F

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

Page 2 - Ms. Pearce

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours;

Sinh.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

1.3 Indications for Use

A. 510(k) Number (if known): K130739

Device Name: S2000 and S3000 Diagnostic Ultrasound Systems

Indications for Use:

The S2000 and S3000 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, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (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.

Virtual Touch Imaging and eSie Touch Elastography provide qualization of relative stiffness between tissues with different elastic properties.

Prescription Use X (Part 21CFR 801 Subpart D) AND/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 In Vitro Diagnostics and Radiological Health (OIR)

Smh.7).

Division Sign-Off

Division of Radiological Health

· Office of In Vitro Diagnostics and Radiological Health

510(k) == K130739 Page 1 of

S2000/3000 510(k) Submission

Page 1 of 26

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S2000 and S3000 Virtual Touch Imaging 510(k) Submission

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

ACUSON S2000/S3000 Ultrasound Systems

Device Name:ACUSON S2000/S3000 Ultrasound SystemsIntended 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		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13, 17
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
Intraoperative(Note 9)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16, 17
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10,15
Cardiac		P	P	P	P	P	P		BMDC	Note 4
Trans-esophageal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Transvaginal
Transurethral
Intravascular		P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8,10,11,14,15
Peripheral vessel
-Laparoscopic-		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 17
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 17
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 3,4,6, 10
Other (specify)Neonatal Cardiac

N = new indication; P = previously cleared by FDA K111674, 121138

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

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 9 For example: vascular, abdominal

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

Note 16

Custom Tissue 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 10 Clarify VE vascular enhancement technology

Note 13 STIC Note 15 AHP

Note 17 VTI

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Division Sign-Off

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k)_

Page 2 of

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Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	CW2 Probe for use with ACUSON S2000/S3000Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	ABMPWDCWDColorDopplerAmplitudeDopplerColorVelocityImagingCombined(Specify)Other(Specify)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic

Fetal	P					P
				P
Abdominal	P					P
				P
Intraoperative(Note 9)	P					P
				P
IntraoperativeNeurological

Pediatric	P					P
				P
Small Organ(Note 1)	P					P
				P
Neonatal Cephalic	P					P
				P
Adult Cephalic	P					P
				P
Cardiac	P					P
				P
Trans-esophageal

Transrectal

Transvaginal

Transurethral

Intravascular

Peripheral vessel	P					P
				P
Laparoscopic

Musculo-skeletalConventional	P					P
				P
Musculo-skeletalSuperficial	P					P
				P
Other (specify)

-N .= . new .indication ; _ R = . previously. cleared. by . F.DA. K # 1.1.1674 ... 12 1.138 _

Additional Comments:

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

Note 9 For example: vascular, abdominal

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	CW5 Probe for use with ACUSON S2000/3000Ultrasound 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 K# 111674, 121138

Additional Comments:

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

Note 9 For example: vascular, abdominal

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:		EC9-4 Curved Array Transducer for use with ACUSON S2000/3000
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,
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 2,3,4,5,6, 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-skeletal-Superficial-
-Other (specify)

N = new indication; P = previously cleared by FDA K# 111674, 121138

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 10 Clarify VE vascular enhancement technology

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

panoramic imaging
panoramic imaging

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Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

9L4 Linear Array Transducer for use with ACUSON S2000/3000 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 2,3,4,5,6,7,8,10, 11,1-16, 17
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic		P	P	P		P	P
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,6, 7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14, 17
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14, 17
"Other (specify)

N = new indication; P = previously cleared by FDA K# 111674, 121138

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis; prostate, etc.
Ensemble tissue hamonic imaging Note 2
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

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

eSie™ Touch elasticity imaging / FTI Note 14 AHP Note 15

Advanced Sieclear spatial compounding

Custom Tissue Imaging

Note 16 Note 17 VTI
Note 11

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

14L5 Multi-D Array Transducer for use with ACUSON S2000/3000 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, 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 K# 111674, 121138

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

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology . Note 10

Advanced Sieclear spatial compounding Note 11

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

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S2000/3000 510(k) Submission

Page 7 of 26

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

S2000 and S3000 Virtual Touch Imaging 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 S2000/3000 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)

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

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C2 Curved Array Transducer for use with ACUSON S2000/3000

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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal"Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 111674, 121138

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Tissue Equalization Technology Note 4

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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 16 Custom Tissue Imaging

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S2000/3000 510(k) Submission

Page 9 of 26

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4C1 Curved Array Transducer for use with ACUSON S2000/3000 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
IntraoperativeAbdominal
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 K# 111674, 121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

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

Note 17 VTI

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S2000/3000 510(k) Submission

Page 10 of 26

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	6C1HD Curved Array Transducer for use with ACUSON S2000/3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10, 11, 14, 16, 17
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ	P	P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 111674, 121138

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

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 VTI

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Page 11 of 26

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4V1 Phased Array Transducer for use with ACUSON S2000/3000 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
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.F.DA K#111674_121.138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
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 16 Custom Tissue Imaging

Note 17 VTI

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S2000/3000 510(k) Submission

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	10V4 Phased Array Transducer for use with ACUSON S2000/3000Ultrasound imaging or fluid flow analysis of the human body as follows:
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)

Additional Comments:

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

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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S2000/3000 510(k) Submission

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Indications For Use:	14L5 SP Linear Array Transducer for use with ACUSON S2000/3000Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 9)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	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# · 1 1 1 6 7 4 - 1 2 1 38 ·

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3

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 5. Fourier slice-scope panoramic imaging
Note 6. Extrahepatic vascular abdominal

Note 9 For example: vascular, abdominal

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

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Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 15 AHP

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	7CF2 Curved array mechanical 3D transducer for use with ACUSON S2000/3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	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
Intraoperative Abdominal
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# 111674, 121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

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

Advanced Sieclear spatial compounding Note 11

Note 13 STIC

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S2000/3000 510(k) Submission

Page 15 of 26

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 9EVF4 Curved Array Transducer for use with ACUSON S2000/3000 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
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-skeletal,Conventional.
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 111674, 121138

Additional Comments:

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 11: Advanced Optical Equation Composer
Note 12: OTIC

Note 13 STIC

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Page 16 of

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	V5Ms Multiplane TEE Transducer for use with ACUSON S2000/3000
Intended Use:Clinical Application	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
	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	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; = P = previously cleared by FDA = K# 1 1 1 6 7 4, 1 2 1 3 8

Additional Comments:

Note 4 Tissue Equalization Technology

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Page 17 of

S2000/3000 510(k) Submission

Page 17 of 26

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

8V3 Phased Array Transducer for use with ACUSON S2000/3000 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
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 3,4,6
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# 111674, 121138

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

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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510{k)________________________________________________________________________________________________________________________________________________________________________

Page 18 of

S2000/3000 510(k) Submission

Page 18 of 26

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

4V1c Phased Array Transducer for use with ACUSON S2000/3000 Device Name: Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Color Color Amplitude Combined Other Clinical Application B PWD CWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P BMDC Note 2 3 4 5 7 8 10 Fetal പ്ര പ്ര న Abdominal P P P P P P BMDC Note 2 3 4 5 7 8 10 Intraoperative BMDC P P P P P P Note 2 3 4 5 7 8 10 Abdominal Intraoperative BMDC p P P P P . P Note 2 3 4 5 7 8 10 Neurological 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 BMDC Note 2 3 4 5 7 8 10 Cardiac P P P P P P 15 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular BMDC Note 2 3 4 5 7 8 10 p P P Peripheral vessel P P P 15 Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify) BMDC P P P P P P Note 2 3 4 5 7 8 10 Neonatal Cardiac

N = new indication; P = previously cleared by FDA K 111674, 121138

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 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

Note 15 AHP

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Page 19 of

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

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	6L3 Transducer for use with ACUSON S2000/3000
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
IntraoperativeAbdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Pediatric
Small Organ		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		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 10,11 15
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Musculo-skeletalSuperficial		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# 111674. 121138

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

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 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 15 AHP

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Page 20 of

{27}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: EV8C4 Transducer for use with ACUSON S2000/3000 Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Color Amplitude Color Combined Other B CWD Clinical Application A M PWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P BMDC Fetal P P P P P Note 2 3 4 5 7 8 10 P BMDC Abdominal P P p P P Note 2 3 4 5 7 8 10 Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal BMDC Note 2 3 4 5 6 7 8 Transvaqinal P P P P പ്ര P 10 Transurethral Intravascular Peripheral vessel

N =- new indication ;- P =- previously cleared by · FDA-K #-1-1-1 674-1-21-1-38-

Additional Comments:

Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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Page 21 of

{28}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	8C3HD Curved Array Transducer for use with ACUSON S3000Ultrasound imaging or fluid flow analysis of the human body as follows:
								Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
IntraoperativeAbdominal
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 K#121138

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

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Page 22 of ___________________________________________________________________________________________________________________________________________________________________

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

S2000/3000 510(k) Submission

Page 22 of 26

{29}------------------------------------------------

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	18L6 HD Linear Array Transducer for use with ACUSON S2000/3000
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
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-skeletal-Superficial		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 K111674, K121138

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

NOTE 14 EUS - Touch Elasticity Imaging / TEI

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Note 15 AHP

Note 16 Custom Tissue Imaging

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Page 23 of

{30}------------------------------------------------

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: V7M TEE Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify) *	HarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	Note 4
IntraoperativeAbdominal
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 # K111674, 121138

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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Page 24 of ____

{31}------------------------------------------------

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter for use with ACUSON S2000/3000 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
Small Organ(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P		P
Peripheral Vessel
Laparoscopic
Musculo-skeletal-Conventional-
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P

P=Previously cleared by the FDA K111674, 121138

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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{32}------------------------------------------------

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter for use with ACUSON S2000/3000 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.

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

P=Previously cleared by the FDA K111674, 121138

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, 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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Page 26 of

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.