Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound imaging modes and measurement packages without mentioning AI/ML capabilities.

Therapeutic

No.
This device is described as a diagnostic ultrasound imaging system, intended for visualizing anatomical structures and providing information for clinical diagnosis, rather than for therapeutic purposes such as treatment or rehabilitation.

Diagnostic

Yes

Explanation: The "Device Description" explicitly states that the S2000 and S3000 Ultrasound Systems are "software controlled diagnostic ultrasound systems." Additionally, the "Intended Use / Indications for Use" section mentions that the calculation packages "provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound systems" and describes its function as acquiring and displaying ultrasound echo data, which requires hardware components (transducers, processing units, display).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the systems are for ultrasound imaging and measurement of anatomical structures. While the measurements and calculations provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes, the primary function is imaging and measurement of the body itself, not testing samples taken from the body.
Device Description: The device description confirms it is a diagnostic ultrasound system that acquires and displays ultrasound echo data. This is consistent with in-vivo imaging, not in-vitro testing.
No mention of testing samples: There is no mention of the device being used to test blood, urine, tissue, or any other sample taken from the patient.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by sending and receiving ultrasound waves to create images and perform measurements within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX, OBJ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, intra-cardiac, intra-luminal, great vessel

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111674, K121138

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K112255, K121329

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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:

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.

5. Intended 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.

Page 7 of 66

Product Code 90-ITX

Product Code OBJ

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 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.

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	Submission
Device
S2000	Submission
Device
S3000	Acuson
S3000
K121138	Acuson
S2000
K111674	Supersonic
Imagine
K112255 /
K121329
● Custom Tissue Imaging / Speed of
Sound	√	√	√	√
● AHP	√	√	√	√
● VTIQ	√	√			√
● 18L6HD Transducer	√	√	√	√
● 6C1HD Transducer	√	√	√	√
● 8C3HD Transducer	√	√	√	√
● Monitor: FPD	√	√	√	√	√
Output Display Standard (Track 3)	√	√	√	√	√
Patient Contact Materials	Tested to ISO
10993-1	Tested to ISO
10993-1	Tested to ISO
10993-1	Tested to ISO
10993-1	Tested to ISO
10993-1
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

2

S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

Page 9 of 66

3

S2000 and S3000 Virtual Touch IQ 510(k) Submission

| | | Supersonic
Imagine | |
|---------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shear Wave Elasticity Imaging Software | VTIQ | Aixplorer | Comments |
| Comparable Exam Types | Breast,
Thyroid | Breast,
Thyroid | |
| Transducer for same Exam Types | 9L4 Multi-D
Linear Array | 10L2, 15L4
Linear Array | |
| Operating Mode | Single Frame | Low Frame
Rate Real
Time | Note 1 |
| Cool Down period before live imaging
resumes | Yes (variable,
~3-6 sec) | No | Note 1 |
| Push Pulse beam density | High
(variable with
FOV size) | Low (variable
with FOV
size)
Reference
Figure 13 in
Supersonic
White Paper | Note 1 |
| Multiple Push Pulse Focal Zones | Yes | "Mach Cone" | In both cases, multiple push pulse focal zones in
depth are used for the purpose of increasing
radiation force uniformity with depth. "Mach
Cone" is the Supersonic term for compound
transmit focusing, similar to Siemens. |
| Two Dimensional Display with Elasticity
Region of Interest | Yes | Yes | |
| Localized Quantitative Shear Wave
Velocity measurement | Yes | Yes -
Predicate not
cleared in the
U.S.A | |
| Localized Quantitative Young's Modulus
measurement | No | Yes -
Predicate not
cleared in the
U.S.A. | Supersonic Imagine has implemented the shear
wave velocity scale in the color bar which
indicates relative shear wave speed in the image
and has been cleared in the U.S. Young's
modulus is not cleared. Siemens VTIQ is
equivalent to Supersonic except Siemens is
requesting clearance for point measurements in
addition to displaying shear wave velocity on the
color bar. When Young's modulus is displayed
(kPa). assumptions are made regarding tissue
density and viscosity that may not be correct in a
wide range of biological tissues and is therefore
an indirect measurement. Shear wave velocity is
a direct measurement. |
| Shear Wave Velocity Display Mode | Yes | Yes | The Shear Wave Quality display assists the user
in interpreting possible shear wave velocity
estimate artifacts in the Shear Wave Velocity
image by indicating in a color coded display the
shear wave magnitude and signal to noise ratio
(SNR) of the shear wave form. This display can
reduce the number of false negative indications
with shear wave imaging in lesions with very high
shear 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 the
dynamic range of the shear wave image in focal
regions of high shear wave velocity as illustrated
in figures 1 and 2 below. |
| Shear Wave Displacement Display Mode | Yes | No | The Shear Wave displacement image provides
information to the user about relative shear wave
amplitudes throughout the shear wave image and
can be useful to correlate regions of high shear
wave attenuation within regions of high shear
modulus to the Shear Wave Quality image. The
Shear Wave Displacement image can also assist
in identifying lesion boundaries. |
| Shear Wave Propagation "Movie" (clip) | No | Yes | Siemens approach to visualizing shear wave
characteristics are the Shear Wave Quality, Time
and Displacement maps. The Supersonic shear
wave propagation movie provides information
specific to their implementation of shear wave
imaging, 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 0.5
m/s to avoid potential artifacts. In in-vivo studies,
shear wave velocities below 0.5 m/s have not
been encountered so there is no impact on
clinical efficacy. |
| "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 | |
| 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

4

:

S2000 and S3000 Virtual Touch IQ 510(k) Submission

S2000/3000 510(k) Submission

·

Page 11 of 66

5

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

6

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

7

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

10

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)

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11

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 Systems
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	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
Intraoperative
Neurological	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	Note
2,3,4,5,6,7,8,10,15
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-skeletal
Conventional	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

P

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

P

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Musculo-skeletal

Neonatal Cardiac

Other (specify)

Superficial

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

11,14, 18

Note 3,4,6, 10

12

510 (k) Number (if known):

Device Name:
Intended Use:							Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological
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-skeletal
Conventional					P
Musculo-skeletal
Superficial					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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13

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological					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-skeletal
Conventional					P
Musculo-skeletal
Superficial					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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14

510 (k) Number (if known):

| Device Name:
Intended Use: | EC9-4 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 | 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 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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 | 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 |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,
14, 18 |
| Musculo-skeletal
Superficial | | 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 S2000/3000
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|--|--|
| Intended Use: | | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological. | | | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11-14 | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| 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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17

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 S2000/3000
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------|
| | Mode of Operation | | | | | | | | | |
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| 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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18

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	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
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Intraoperative
Abdominal
Intraoperative
Neurological
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-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

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 S2000/3000
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------------|
| | | Mode of Operation | | | | | | | | |
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | 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:

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	Color
Doppler	Amplitude
Doppler	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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Page 11 of ___________________________________________________________________________________________________________________________________________________________________

21

.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	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
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
14, 16, 17
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:

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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Page 12 of ___________________________________________________________________________________________________________________________________________________________________

22

510 (k) Number (if known):

| 10V4 Phased 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							Other
(Specify)
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging		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
Intraoperative
Abdominal
Intraoperative
Neurological
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-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

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)_

Page 13 of _

23

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 9)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Neurological		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	Note2,3,4,5.6
7,8,10, 11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial
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 | 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:

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	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-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

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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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· 510(k)_

Page 18 of ___________________________________________________________________________________________________________________________________________________________________

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Neurological	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 10
15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
15
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 S2000/3000
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 | | | | | | | | | BMDC | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10,
11 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10,
11 | |
| Intraoperative
Neurological | | 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 10
15 | |
| 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-skeletal
Conventional | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10,
11 | |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | | 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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.

510(k)________________________________________________________________________________________________________________________________________________________________________

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Abdominal
Intraoperative
Neurological
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 8
10
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:

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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 S2000/3000
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|--|--|
| Clinical Application | Mode of Operation | | | | | | | | | | | |
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 | | |
| Musculo-skeletai
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:

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

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Note 15 AHP

Note 16 Custom Tissue Imaging

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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 | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) * | Harmonic
Imaging | Other
(Specify) |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P | P | Note 4 |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| 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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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	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
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-skeletal
Conventional
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+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	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
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-skeletal
Conventional
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+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

(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) '

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