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, 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 adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

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

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.

AI/ML Overview

The provided document is a 510(k) summary for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, focusing on their Virtual Touch IQ (VTIQ) shearwave elasticity imaging software. The document primarily establishes substantial equivalence to predicate devices and outlines the device's technical characteristics and intended uses.

Here's an analysis of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the VTIQ feature. Instead, it argues for substantial equivalence based on technological characteristics and a comparison with the predicate device (Supersonic Imagine Aixplorer).

Feature / Characteristic	Predicate Device (Aixplorer)	Submission Device (Siemens VTIQ)	Comments / Performance
Shear Wave Elasticity Imaging Software	Aixplorer	VTIQ	Comparable exam types and functionality. Siemens is requesting clearance for point measurements in addition to displaying shear wave velocity on the color bar. Siemens VTIQ is stated to achieve higher signal to noise ratio and more consistent shearwave velocity estimation based on in-vivo studies.
Comparable Exam Types	Breast, Thyroid	Breast, Thyroid	-
Transducer for same Exam Types	10L2, 15L4 Linear Array	9L4 Multi-D Linear Array	-
Operating Mode	Low Frame Rate Real Time	Single Frame	VTIQ's single-frame acquisition allows for higher SNR without image compounding, contrasted with the predicate's lower frame rate and need for compounding.
Cool Down Period before Live Imaging Resumes	No	Yes (variable, ~3-6 sec)	A difference noted, but not tied to specific acceptance criteria.
Push Pulse Beam Density	Low (variable with FOV size)	High (variable with FOV size)	Explained as a factor contributing to higher SNR in VTIQ.
Multiple Push Pulse Focal Zones	"Mach Cone"	Yes	Both use for increased radiation force uniformity.
Two Dimensional Display with Elasticity Region of Interest	Yes	Yes	-
Localized Quantitative Shear Wave Velocity Measurement	Yes - Predicate not cleared in U.S.A.	Yes	Siemens VTIQ requests clearance for this.
Localized Quantitative Young's Modulus Measurement	Yes - Predicate not cleared in U.S.A.	No	Siemens chose not to include Young's Modulus due to assumptions needed (tissue density, viscosity) that may not be correct, preferring direct shear wave velocity.
Shear Wave Velocity Display Mode	Yes	Yes	-
Shear Wave Quality Display Mode	No	Yes	Assists user in interpreting possible shear wave velocity estimate artifacts.
Shear Wave Travel Time Display Mode	No	Yes	Improves dynamic range of shear wave image in focal regions of high shear wave velocity.
Shear Wave Displacement Display Mode	No	Yes	Provides information on relative shear wave amplitudes, useful for identifying lesion boundaries and correlating with attenuation.
Shear Wave Propagation "Movie" (clip)	Yes	No	Siemens uses its own display modes (Quality, Time, Displacement) to visualize shear wave characteristics.
Shear Wave Velocity Measurement Range	0.1-10 m/sec	0.5-10 m/sec	Siemens opted for a higher lower cutoff (0.5 m/s) to avoid potential artifacts, stating that velocities below this are not encountered in vivo.
"See through to B mode" when no shear wave detected	Yes	Yes	-
Color Coded Shear Wave Velocity Display	Yes	Yes	-
Adjustable Maximum and Minimum Velocity Scale	Yes	Yes	-
In Color Code. Red is 'stiff' and blue is 'soft'	Yes	Yes	-
Color map is transparent over B mode display	Yes	Yes	-

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

The document does not explicitly mention a formalized "test set" with a specified sample size for validating the VTIQ feature against acceptance criteria. It mentions:

"Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers."
"25 example cases submitted (refer to tab 1.7.5.10 D)."

This suggests some form of comparative evaluation on a limited set of cases (at least 25), but details regarding the design of this study (e.g., sample size, prospective/retrospective, country of origin) are missing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document mentions "biopsy proven breast cancers" as a reference for comparison in the aforementioned "many cases." This implies pathology as ground truth. However, the exact number of experts (e.g., pathologists) involved in establishing this ground truth for the "25 example cases" or more generally for the "many cases" is not specified, nor are their specific qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set or the "many cases" mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. It describes a comparison between the VTIQ device and a predicate device, focusing on technical performance differences rather than human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document implies a standalone comparison of the VTIQ algorithm's output (shear wave velocity, image quality) against the predicate device's output. The statement, "Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers," highlights an algorithm-only comparison of the imaging capabilities and derived measurements.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth mentioned that is relevant to disease state is histopathological diagnosis ("biopsy proven breast cancers").

8. The Sample Size for the Training Set

The document does not provide information on a specific training set or its sample size. This filing is a 510(k) for an ultrasound system with new software features, implying that the VTIQ algorithm was likely developed internally and possibly trained on proprietary data which is not described in this summary.

9. How the Ground Truth for the Training Set Was Established

Since no training set information is provided, how its ground truth was established is also not available in the document.

Summary

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K130881
Page 1 of 8

$2000 and S3000 Virtual Touch IC 510(k) Submission

510(k) Summarv Prepared March 26, 2013 1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043 Contact Person: Shelly Pearce Telephone: (650) 694-5988 (650) 694-5580 Fax: Acuson S2000 and S3000 Diagnostic Ultrasound Systems 2. Device Name: Common Name: Diagnostic Ultrasound System Classification: OCT 1 1 2013 Regulatory Class: = 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

3. Legally Marketed Predicate Devices

Diagnostic Ultrasound Transducer Diagnostic Ultrasound Catheter

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)

FR # 892.1570

FR # 870.1200

4. Device Description:

5. Intended Use

Page 7 of 66

Product Code 90-ITX

Product Code OBJ

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Feature / Characteristic	Submission Device S2000	Submission Device S3000	Acuson S3000 K121138	Acuson S2000 K111674	Supersonic Imagine K112255 / K121329
Indications for Use:
Fetal	√	√	√	√
Abdominal	√	√	√	√	√
Intraoperative abdominal and vascular	√	√	√	√
Intraoperative neurological	--	--	--	--	--
Pediatric	√	√	√	√	√
Small Organ	√	√	√	√	√
Neonatal cephalic	√	√	√	√
Adult Cephalic	√	√	√	√
Cardiac	√	√	√	√
Trans-esophageal	√	√	√	√
Transrectal	√	√	√	√	√
Transvaginal	√	√	√	√	√
Peripheral vessel	√	√	√	√	√
Laparoscopic	--	--	--	--	--
Musculo-skeletal (conventional)	√	√	√	√	√
Musculo-skeletal (superficial)	√	√	√	√	√
Center Frequencies Supported:
2.0 MHz	√	√	√	√	√
3.0 MHz	√	√	√	√	√
3.2 MHz	√	√	√	√	√
Feature / Characteristic	Submission Device S2000	Submission Device S3000	Acuson S3000 K121138	Acuson S2000 K111674	Supersonic Imagine K112255/ K121329
3.3 MHz	√	√	√	√	√
4.2 MHz	√	√	√	√	√
4.4 MHz	√	√	√	√	√
4.8 MHz	√	√	√	√	√
5.0 MHz	√	√	√	√	√
5.2 MHz	√	√	√	√	√
6.0 MHz	√	√	√	√	√
6.5 MHz	√	√	√	√	√
6.9 MHz	√	√	√	√	√
9.5 MHz	√	√	√	√	√
10.0 MHz	√	√	√	√	√
Modes:
B	√	√	√	√	√
Parallel processing in B mode	√	√	√	√	√
M	√	√	√	√
PWD (Pulsed Wave Doppler)	√	√	√	√	√
CWD (Continuous Wave Doppler)	√	√	√	√	√
D (Color Doppler)	√	√	√	√	√
Amplitude Doppler	√	√	√	√	√
Combined (BMDC)	√	√	√	√	√
Features:
Quad processing in color	√	√		√
Native™ tissue harmonic imaging	√	√	√	√
SieScape™ panoramic imaging	√	√	√	√
Color SieScape™ panoramic imaging	√	√	√	√
3-Scape™ real-time 3D imaging	√	√	√	√
fourSight™ 4D transducer technology	√	√	√	√
TEQ™ ultrasound technology	√	√	√	√
Extend imaging technology	√	√	√	√
Cardiac Imaging physiological signal display	√	√	√	√
syngo ® Auto OB measurements	√	√	√	√
Advanced SieClear™ spatial compounding	√	√	√	√
STIC (Fetal Heart Imaging)	√	√	√	√
Amnioscopic rendering	√	√	√	√
Cadence contrast agent imaging	√	√	√	√
Clarify™ vascular enhancement technology	√	√	√	√
eSie™ Touch elasticity imaging	√	√	√	√	√
syngo ® Auto Left heart	√	√	√	√
syngo ® Velocity Vector Imaging	√	√	√	√
Semi Auto-segmentation (eSie Calc)	√	√	√	√
Feature / Characteristic	SubmissionDeviceS2000	SubmissionDeviceS3000	AcusonS3000K121138	AcusonS2000K111674	SupersonicImagineK112255 /K121329
● Custom Tissue Imaging / Speed ofSound	√	√	√	√
● AHP	√	√	√	√
● VTIQ	√	√			√
● 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

the submit the state of the same of the same of the subject of

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S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

Page 9 of 66

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S2000 and S3000 Virtual Touch IQ 510(k) Submission

		SupersonicImagine
Shear Wave Elasticity Imaging Software	VTIQ	Aixplorer	Comments
Comparable Exam Types	Breast,Thyroid	Breast,Thyroid
Transducer for same Exam Types	9L4 Multi-DLinear Array	10L2, 15L4Linear Array
Operating Mode	Single Frame	Low FrameRate RealTime	Note 1
Cool Down period before live imagingresumes	Yes (variable,~3-6 sec)	No	Note 1
Push Pulse beam density	High(variable withFOV size)	Low (variablewith FOVsize)ReferenceFigure 13 inSupersonicWhite Paper	Note 1
Multiple Push Pulse Focal Zones	Yes	"Mach Cone"	In both cases, multiple push pulse focal zones indepth are used for the purpose of increasingradiation force uniformity with depth. "MachCone" is the Supersonic term for compoundtransmit focusing, similar to Siemens.
Two Dimensional Display with ElasticityRegion of Interest	Yes	Yes
Localized Quantitative Shear WaveVelocity measurement	Yes	Yes -Predicate notcleared in theU.S.A
Localized Quantitative Young's Modulusmeasurement	No	Yes -Predicate notcleared in theU.S.A.	Supersonic Imagine has implemented the shearwave velocity scale in the color bar whichindicates relative shear wave speed in the imageand has been cleared in the U.S. Young'smodulus is not cleared. Siemens VTIQ isequivalent to Supersonic except Siemens isrequesting clearance for point measurements inaddition to displaying shear wave velocity on thecolor bar. When Young's modulus is displayed(kPa). assumptions are made regarding tissuedensity and viscosity that may not be correct in awide range of biological tissues and is thereforean indirect measurement. Shear wave velocity isa direct measurement.
Shear Wave Velocity Display Mode	Yes	Yes	The Shear Wave Quality display assists the userin interpreting possible shear wave velocityestimate artifacts in the Shear Wave Velocityimage by indicating in a color coded display theshear wave magnitude and signal to noise ratio(SNR) of the shear wave form. This display canreduce the number of false negative indicationswith shear wave imaging in lesions with very highshear modulus that attenuate the shear wave.
Shear Wave Quality Display Mode	Yes	No
Shear Wave Travel Time Display Mode	Yes	No	Shear Wave Travel Time display improves thedynamic range of the shear wave image in focalregions of high shear wave velocity as illustratedin figures 1 and 2 below.
Shear Wave Displacement Display Mode	Yes	No	The Shear Wave displacement image providesinformation to the user about relative shear waveamplitudes throughout the shear wave image andcan be useful to correlate regions of high shearwave attenuation within regions of high shearmodulus to the Shear Wave Quality image. TheShear Wave Displacement image can also assistin identifying lesion boundaries.
Shear Wave Propagation "Movie" (clip)	No	Yes	Siemens approach to visualizing shear wavecharacteristics are the Shear Wave Quality, Timeand Displacement maps. The Supersonic shearwave propagation movie provides informationspecific to their implementation of shear waveimaging, as noted in Note 1.
Shear Wave Velocity Measurement Range	0.5-10 m/sec	0.1-10 m/sec	Siemens has chosen a lower velocity cutoff of 0.5m/s to avoid potential artifacts. In in-vivo studies,shear wave velocities below 0.5 m/s have notbeen encountered so there is no impact onclinical efficacy.
"See through to B mode" when no shearwave detected	Yes	Yes
Color Coded Shear Wave Velocity Display	Yes	Yes
Adjustable Maximum and MinimumVelocity Scale	Yes	Yes
In Color Code. Red is 'stiff' and blue is'soft'	Yes	Yes
Color map is transparent over B modedisplay	Yes	Yes
Other system features:
B Mode Imaging	Yes	Yes
Pulse Wave Doppler Imaging	Yes	Yes
Color Flow Doppler Imaging	Yes	Yes
Spatial Compound Imaging	Yes	Yes
Speckle Reduction Image Processing	Yes	Yes
Tissue Harmonic Imaging	Yes	Yes

Page 10 of 66

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S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

Page 11 of 66

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S2000 and S3000 Virtual Touch IQ 510(k) Submission

Note 1:

There are differences in push pulse sequencing and shearwave detection between the predicate device (Supersonic Aixplorer) and Siemens VTIQ. Siemens uses closely spaced focused push beams and a large number of closely spaced focused detection beams resulting in higher signal to noise ratio in shearwave imaging than the predicate device. We attribute this to several factors, including wide spacing of push beams on the Aixplorer, plane wave detection of shearwaves over a wide area on the Aixplorer resulting in signal to noise limitations and a higher frequency transducer (15L4 on Aixplorer vs 9L4 on VTIQ) that results in higher shearwave attenuation with the predicate device. Additionally, a reduced push beam mechanical index is used on the Aixplorer as compared to the constant value of 1.7 with VTIQ. which allows pseudo-real time operation on the Aixplorer of approximately 1 frame per second. The user is required to compound the image at the region of interest over several seconds with the Aixplorer to allow the image to "build up" over several frames to improve signal to noise ratio. VTIQ is a single frame image acquisition that allows higher signal to noise ratio without image compounding and generates a more consistent shearwave velocity estimation based on our experience in in-vivo studies. Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers. In many cases the maximum velocity on the predicate device fell far below the threshold cutoff of 80 kPa (~5.2 m/s) indicated in the Supersonic BE1 study for malignancy as indicated in the 25 example cases submitted (refer to tab 1.7.5.10 D).

Image /page/5/Picture/5 description: The image shows two ultrasound images comparing SW Velocity and SW Time. The top image shows a lesion boundary in SW Velocity, while the bottom image shows a lesion boundary in SW Time. The text on the right side of the image indicates that the images are related to ILC anterior to a breast implant. The image is labeled as "Figure 1".

S2000/3000 510(k) Submission

Page 12 of 66

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Image /page/6/Figure/2 description: The image shows a diagram of a wave source with two detection points, T1 and T2, along with a graph illustrating the relationship between velocity and travel time. The formula for velocity (v) is given as v = (x2-x1) / (T2-T1). The graph shows two curves, one for T1 and one for T2, plotting velocity against travel time, indicating an inverse relationship where high velocity corresponds to low travel time and vice versa. The text explains that in shear wave velocity imaging, the distance between detection locations is constant, and the inverse relationship between velocity and travel time means that travel time display has a high dynamic range at low velocity, while velocity display has a high dynamic range at high velocity.

Relationship of SW Velocity and SW Travel Time Displays

Figure 2

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

UL 60601-1, Safety Requirements for Medical Equipment .
. IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . .
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ● Acoustic Output Indices on Diagnostic Ultrasound Equipment
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
- . 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.

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

The S2000. $3000 and Aixplorer use the same technology and principles as existing devices. clinical data is not required.

9. Summarv

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR

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Page 8 of 8

S2000 and S3000 Virtual Touch IQ 510(k) Submission

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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 caduceus, with three parallel lines curving upwards and to the right.

Public Health Service

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

October 11, 2013

Siemens Medical Solutions, Inc. % Ms Shelly Pearce Regulatory Affairs 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K130881

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: IYN, IYO, ITX, OBJ Dated: October 3, 2013 Received: October 4, 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 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

CWS 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4V1c Phased Array 8C3HD Curved Array AcuNav 8F

EC9-4 Curved Array 4P1 Phased Array 6C1HD Curved Array 141.5 SP Linear Array V5Ms Multiplane TEE 613 18L6 HD Linear Array AcuNav 10F

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

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 (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.

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 tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sm.h.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

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Indications for Use 1.3

A. 510(k) Number (if known): K130881

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, Supericial 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.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

AND/OR

Prescription Use _ × (Part 21CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801

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)

Page 1 of 26

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1.3 Indications for Use Forms	Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:Intended Use:	ACUSON S2000/S3000 Ultrasound SystemsUltrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	P	P	P	P	P	P	P			Note 2,3,4,5,7,8,10
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 13
Abdominal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 13
Intraoperative(Note 9)	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
IntraoperativeNeurological	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 14
Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Small Organ(Note 1)	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14, 16, 18
Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Cardiac	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,6,7,8,10,15
Trans-esophageal	P	P	P	P	P	P	P		BMDC	Note 4
Transrectal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Transvaginal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14, 18

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 Nate 5 B&W SieScape panoramic imaging

Note 7 Note 9 For example: vascular, abdominal

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Custom Tissue Imaging Note 16

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

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

BMDC

te 15 AHP

Note 15 AHP
Note 18 VTIQ

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Musculo-skeletal

Neonatal Cardiac

Other (specify)

Superficial

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510(k)

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Note 2,3,4,5,7,8,10.

11,14, 18

Note 3,4,6, 10

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510 (k) Number (if known):

Device Name:							CW2 Probe for use with ACUSON S2000/S3000
Intended Use:									Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					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# 111674, 121138

Additional Comments:

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

For example: vascular, abdominal Note 9

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510 (k) Number (if known):

Device Name: Intended Use:

CW5 Probe 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
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:

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

Note 9 For example: vascular, abdominal

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510 (k) Number (if known):

Device Name:Intended Use:	EC9-4 Curved Array Transducer 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	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-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 10 Clarify VE vascular enhancement technology Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

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Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

S2000/3000 510(k) Submission

Page 5 of 26

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S2000 and S3000 Virtual Touch IQ 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:

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
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, 11,14,16, 18
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, 18
Musculo-skeletalSuperficial	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11,14, 18
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
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
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10

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

Note 14 AHP
Note 15
Custom Tissue Imaging Note 16
Note 18 VTIQ

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

510 (k) Number (if known):

Device Name:	14L5 Multi-D Array Transducer for use with ACUSON S2000/3000Ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Nole 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

Note 11 Advanced Sieclear spatial compounding

eSie™ Touch elasticity imaging / FTI Note 14

Custom Tissue Imaging Note 16

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Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:Clinical Application	4P1 Phased Array Transducer for use with ACUSON S2000/3000Ultrasound 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		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-skeletal
Superficial
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

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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510 (k) Number (if known):

Device Name: Intended Use: 6C2 Curved Array Transducer for use with ACUSON S2000/3000 Ultrasound 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		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-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

Note 7 B&W SieScape panoramic imaging

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

Note 14 eSie™ Touch elasticity imaging / FTI

SieClear multi-view spatial compounding Note 3

Note 5 3-Scape real-time 3D imaging

Power SieScape panoramic imaging Note 8

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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

S2000 and S3000 Virtual Touch IQ 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:Clinical Application	4C1 Curved Array Transducer for use with ACUSON S2000/3000Ultrasound 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		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
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:

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4
Note 6 Cadence contrast agent imaging
Power SieScape panoramic imaging Note 8
Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

SieClear multi-view spatial compounding Note 3
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

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

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:
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color Velocity Imaging	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
Intraoperative Abdominal
Intraoperative Neurological
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-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
Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Power SieScape panoramic imaging Note 8

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

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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.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 FDA K# 111674, 121138

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Note 4 Tissue Equalization Technology

B&W SieScape panoramic imaging Note 7

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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· · · ·

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510 (k) Number (if known):

10V4 Phased Array Transducer for use with ACUSON S2000/3000Ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation								Other(Specify)
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging		Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
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
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi view spatial compounding Note 3

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

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・

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510 (k) Number (if known):

Device Name:	14L5 SP Linear Array Transducer for use with ACUSON S2000/3000
Indications For Use:	Diagnostic 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	Note2,3,4,5.67,8,10, 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# 111674, 121138

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
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
Power SieScape panoramic imaging Note 8
For example: vascular, abdominal Note 9
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding

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Page 14 വ് _____

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 15 AHP

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

510 (k) Number (if known):

7CF2 Curved array mechanical 3D 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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11,13
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-skeletal
Conventional
Musculo-skeletalSuperficial
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

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 13 STIC

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510(k)_

Page 15 of ___________________________________________________________________________________________________________________________________________________________________

S2000/3000 510(k) Submission

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

S2000 and S3000 Virtual Touch IQ 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-skeletalConventional
Musculo-skeletalSuperficial
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

Note 4 Tissue Equalization Technology

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 13 STIC

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Page 16 of ___________________________________________________________________________________________________________________________________________________________________

S2000/3000 510(k) Submission

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

510 (k) Number (if known):

Device Name:	V5Ms Multiplane TEE 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
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# 111674, 121138

Additional Comments:

Note 4 Tissue Equalization Technology

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Page 17 of _

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

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

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

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

Page 18 of 26

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

S2000 and S3000 Virtual Touch IQ 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4V1c 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	P		BMDC	Note 2 3 4 5 7 8 10
Abdominal	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeAbdominal	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeNeurological	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Pediatric	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Cardiac	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac	P	P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

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

Note 15 AHP

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Page 19 of ___________________________________________________________________________________________________________________________________________________________________

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

510 (k) Number (if known):

Device Name:Intended Use:	6L3 Transducer 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									BMDC
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

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

Note 11 Advanced Sieclear spatial compounding

Note 15 AHP

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Page 20 of ___________________________________________________________________________________________________________________________________________________________________

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

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
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
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 6 7 810
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

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

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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Page 21 of ___________________________________________________________________________________________________________________________________________________________________

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

510 (k) Number (if known):

Device Name:	8C3HD Curved Array Transducer for use with ACUSON S3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic										Note 2,3,4,5,7,8,10,11
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

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

Power SieScape panoramic imaging Note 8

Note 10. Clarify VF vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

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510(k)_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Page 22 of _

S2000/3000 510(k) Submission

Page 22 of 26

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

ic imaging
oramic imaging
hancement technology

Note 10 Clarify VE vascular enhancement technology

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

510 (k) Number (if known):

Device Name:Intended Use:	18L6 HD Linear Array Transducer for use with ACUSON S2000/3000Ultrasound 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
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		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-skeletaiSuperficial		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:

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

B&W SieScape panoramic imaging Note 7

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

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

Note 15 AHP

Note 16 Custom Tissue Imaging

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Page 23 of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{33}------------------------------------------------

S2000 and S3000 Virtual Touch IQ 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Combined(Specify) *	HarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	Note 4
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
Tissue Equalization Technology Note 4
Note 10 Clarify VE vascular enhancement technology

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Page 24 of

{34}------------------------------------------------

510 (k) Number (if known):

AcuNav 8F Ultrasound Catheter for use with ACUSON S2000/3000 Device Name: Catheter is intended for intra-cardiac and intraluminal visualization of cardiac Intended Use: and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
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-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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Page 25 of _

{35}------------------------------------------------

�

Diaqnostic 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.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
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-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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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.