Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The intended use and device description clearly state that the system is a "diagnostic ultrasound system" for imaging and measurement, not for therapeutic purposes.

Diagnostic

Yes

The "Device Description" explicitly states that the S2000 and S3000 systems are "diagnostic ultrasound systems." Additionally, the "Intended Use / Indications for Use" section mentions that the derived information provides "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 mentions hardware components like a "Flat Panel Display" and the ability to acquire "ultrasound echo data," indicating it is a hardware system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The S2000 and S3000 ultrasound systems are described as "multi-purpose mobile, software controlled diagnostic ultrasound systems." They acquire and display ultrasound echo data to visualize anatomical structures and provide measurements.
Intended Use: The intended uses listed are all related to in vivo imaging and measurement of structures within the body (Fetal, Abdominal, Cardiac, Vascular, etc.).
No mention of samples: There is no mention of the device analyzing samples taken from the body.

While the device provides information that can be used "adjunctively with other medical data obtained by a physician for clinical diagnosis purposes," this information is derived from imaging the body directly, not from analyzing biological samples in vitro.

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, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adiunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

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

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

Not Found

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, Intraoperative neurological, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Intra-cardiac, Intra-luminal (great vessel anatomy)

Indicated Patient Age Range

Adult and Pediatric (for AcuNav Ultrasound Catheter), Neonatal/Adult (for Cephalic applications).

Intended User / Care Setting

Physician / Not Found

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)

Nonclinical tests were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic and mechanical safety. The device conforms with applicable medical device safety standards. Additional testing was performed to compare El to VTI by validating intra-operator and interoperator reproducibility of VTI using El as a benchmark. Visual comparison of phantom images generated with El and VTI demonstrate more consistent contrast to noise ratio and clearer inclusion visualization with VTI than with EI. Clinical data is not required as the S2000 and S3000 use the same technology and principles as existing devices.

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, K112255, K121329

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.

Not Found

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

510(k) Summary Prepared March 12, 2013

JUN 6 2013

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

| Contact Person: | Shelly Pearce
Telephone:
Fax: | (650) 694-5988
(650) 694-5580 |

-----------------	-------------------------------------	----------------------------------

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

Classification:

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

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

3. Legally Marketed Predicate Devices

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

4. Device Description:

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.

1

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adiunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

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

| | Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Acuson
Antares
K063138 |
|---------------------------------------------------|------------------------------------------|-------------------------------|-------------------------------|----------------------------|------------------------------|------------------------------|
| | 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 | √ | √ | √ | √ | √ |
| Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Acuson
Antares
K063138 | |
| ■ 3.0 MHz | √ | √ | √ | √ | √ | |
| ■ 3.2 MHz | √ | √ | √ | √ | √ | |
| ■ 3.3 MHz | √ | √ | √ | √ | √ | |
| ■ 4.2 MHz | √ | √ | √ | √ | √ | |
| ■ 4.4 MHz | √ | √ | √ | √ | √ | |
| ■ 4.8 MHz | √ | √ | √ | √ | √ | |
| ■ 5.0 MHz | √ | √ | √ | √ | √ | |
| ■ 5.2 MHz | √ | √ | √ | √ | √ | |
| ■ 6.0 MHz | √ | √ | √ | √ | √ | |
| ■ 6.5 MHz | √ | √ | √ | √ | √ | |
| ■ 6.9 MHz | √ | √ | √ | √ | √ | |
| ■ 9.5 MHz | √ | √ | √ | √ | √ | |
| ■ 10.0 MHz | √ | √ | √ | √ | √ | |
| Modes: | | | | | | |
| ■ B | √ | √ | √ | √ | √ | |
| ■ Parallel processing in B mode | √ | √ | √ | √ | √ | |
| ■ M | √ | √ | √ | √ | √ | |
| ■ PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ | |
| ■ CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ | |
| ■ D (Color Doppler) | √ | √ | √ | √ | √ | |
| ■ Amplitude Doppler | √ | √ | √ | √ | √ | |
| ■ Combined (BMDC) | √ | √ | √ | √ | √ | |
| Features: | | | | | | |
| Quad processing in color | √ | √ | √ | √ | √ | |
| ■ Native™ tissue harmonic imaging | √ | √ | √ | √ | √ | |
| ■ SieScape™ panoramic imaging | √ | √ | √ | √ | √ | |
| ■ Color SieScape™ 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 | √ | √ | √ | √ | √ | |
| ■ eSie Fusion | | √ | √ | | | |
| Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Acuson
Antares
K063138 | |
| • syngo ® Velocity Vector Imaging | √ | √ | √ | √ | √ | |
| • Semi Auto-segmentation (eSie
Calc) | √ | √ | √ | √ | √ | |
| • Custom Tissue Imaging / Speed of
Sound | √ | √ | √ | √ | √ | |
| • AHP | √ | √ | √ | √ | √ | |
| • VTI | √ | √ | √ | √ | √ | |
| • 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

2

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

.

:

3

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

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

UL 60601-1, Safety Requirements for Medical Equipment .
. IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment 비
AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AIUM/NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive .
Safety and EMC Requirements for Medical Equipment
- =
- EN/IEC 60601-1-1 .
- . EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility .

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

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

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

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

4

9. Summary

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

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

June.6, 2013

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

Re: K130739

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

Dear Ms. Pearce:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device. subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling. and prohibitions against misbranding and adulteration .- Please note:- CDRH-does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Transducer Model Number

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

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

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

6

Page 2 - Ms. Pearce

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours;

Sinh.7)

for

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

Enclosure

7

1.3 Indications for Use

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

Device Name: S2000 and S3000 Diagnostic Ultrasound Systems

Indications for Use:

The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac. Pelvic. Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

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

Prescription Use X (Part 21CFR 801 Subpart D) AND/OR

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

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

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

Smh.7).

Division Sign-Off

Division of Radiological Health

· Office of In Vitro Diagnostics and Radiological Health

510(k) == K130739 Page 1 of

S2000/3000 510(k) Submission

Page 1 of 26

8

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

ACUSON S2000/S3000 Ultrasound Systems

| Device Name:
ACUSON S2000/S3000 Ultrasound Systems
Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13, 17
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14
Intraoperative
(Note 9)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14
Intraoperative
Neurological		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 16, 17
Small Organ
(Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note
2,3,4,5,6,7,8,10,15
Cardiac		P	P	P	P	P	P	BMDC	Note 4
Trans-esophageal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Transvaginal
Transurethral
Intravascular		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10,
11,14,15
Peripheral vessel
-Laparoscopic-		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 17
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 17
Musculo-skeletal
Superficial		P	P	P	P	P	P	BMDC	Note 3,4,6, 10
Other (specify)
Neonatal Cardiac

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

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

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 9 For example: vascular, abdominal

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

Note 16

Custom Tissue Imaging

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 13 STIC Note 15 AHP

Note 17 VTI

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Page 2 of

9

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | CW2 Probe Ultrasound imaging or fluid |----------------------------------| | | Clinical Application DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify) | A | B | M | PWD Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| A | B 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) | | | for use with ACUSON S2000/S3000
flow analysis of the human body as follows: | | | | | | | | | | |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Mode of Operation | | | | | | | | | | |
| ABMPWDCWDColor
| CWD | Color
| M | PWD | CWD | Color
| |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | P | | | | | |
| | | P | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |

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

Additional Comments:

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

Note 9 For example: vascular, abdominal

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10

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | CW5 Probe for use with ACUSON S2000/3000
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:

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

Note 9 For example: vascular, abdominal

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11

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:		EC9-4 Curved Array Transducer for use with ACUSON S2000/3000
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

panoramic imaging
panoramic imaging

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Page 5 of

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

12

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

9L4 Linear Array Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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, 11,1-
16, 17
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic		P	P	P		P	P
Cardiac		P	P	P		P	P	BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,6, 7,8,10, 11,
14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11,
14, 17
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11,
14, 17
"Other (specify)

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

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis; prostate, etc.
Ensemble tissue hamonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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

Advanced Sieclear spatial compounding

Custom Tissue Imaging

Note 16 Note 17 VTI
Note 11

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Page 6 of

13

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 6 . Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology . Note 10

Advanced Sieclear spatial compounding Note 11

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

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S2000/3000 510(k) Submission

Page 7 of 26

14

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4P1 Phased Array Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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)

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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Page 8 of

15

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

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

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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:

Ensemble tissue harmonic imaging Note 2
Tissue Equalization Technology Note 4

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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Page 9 of

S2000/3000 510(k) Submission

Page 9 of 26

16

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4C1 Curved Array Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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, 17
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
Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

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

Note 17 VTI

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·

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Page 10 of

S2000/3000 510(k) Submission

Page 10 of 26

17

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	6C1HD Curved Array Transducer for use with ACUSON S2000/3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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,
11
Abdominal	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,
10, 11, 14, 16, 17
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P	BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC
Laparoscopic
Musculo-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

Note 8 Power SieScape panoramic imaging

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 VTI

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S2000/3000 510(k) Submission

Page 11 of 26

18

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

4V1 Phased Array Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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.F.DA K#111674_121.138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 3 SieClear multi view spatial compounding Note 5 3-Scape real-time 3D imaging
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging

Note 17 VTI

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S2000/3000 510(k) Submission

Page 12 of 26

19

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | 10V4 Phased Array Transducer for use with ACUSON S2000/3000
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 | 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 | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 3,4 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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Page 13 of

S2000/3000 510(k) Submission

Page 13 of 26

20

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Indications For Use: | 14L5 SP Linear Array Transducer for use with ACUSON S2000/3000
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 | Note 2,3,4,5,6
,7,8,10, 11,14,15 | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | | |
| Other_(specify) | | | | | | | | | | | | | | |

N =- new indication ;- P =- previously cleared by · FDA · K# · 1 1 1 6 7 4 - 1 2 1 38 ·

Additional Comments:

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

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

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

Note 9 For example: vascular, abdominal

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

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Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 15 AHP

21

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	7CF2 Curved array mechanical 3D transducer for use with ACUSON S2000/3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11, 13
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
"Other" (specify)

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Advanced Sieclear spatial compounding Note 11

Note 13 STIC

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Page 15 of

S2000/3000 510(k) Submission

Page 15 of 26

22

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 9EVF4 Curved Array Transducer for use with ACUSON S2000/3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 11: Advanced Optical Equation Composer
Note 12: OTIC

Note 13 STIC

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Page 16 of

23

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	V5Ms Multiplane TEE Transducer for use with ACUSON S2000/3000
Intended Use:
Clinical Application	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
	A	B	M	PWD	CWD	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# 1 1 1 6 7 4, 1 2 1 3 8

Additional Comments:

Note 4 Tissue Equalization Technology

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S2000/3000 510(k) Submission

Page 17 of 26

24

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

s

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

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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510{k)________________________________________________________________________________________________________________________________________________________________________

Page 18 of

S2000/3000 510(k) Submission

Page 18 of 26

25

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

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

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

Note 15 AHP

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Page 19 of

26

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	6L3 Transducer for use with ACUSON S2000/3000
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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
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

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging . Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 15 AHP

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Page 20 of

27

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

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

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

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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Page 21 of

28

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | 8C3HD Curved Array Transducer for use with ACUSON S3000
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 2,3,4,5,7,8,10,
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

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

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

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Page 22 of ___________________________________________________________________________________________________________________________________________________________________

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

S2000/3000 510(k) Submission

Page 22 of 26

29

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	18L6 HD Linear Array Transducer for use with ACUSON S2000/3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	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	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-skeletal-
Superficial		P	P	P		P	P	BMDC	-Note 2,3,4,5,7,8,10,-
-11,14-
Other (specify)

N = new indication; P = previously cleared by FDA K111674, K121138

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

NOTE 14 EUS - Touch Elasticity Imaging / TEI

(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

30

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

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

| Clinical Application | 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
Note 4 Tissue Equalization Technology

Note 10 Clarify VE vascular enhancement technology

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Page 24 of ____

31

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative
(Vascular)
Intraoperative
(Neurological)
Pediatric		P	P	P	P	P	P	P
Small Organ
(Specify) **
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P	P
Peripheral Vessel
Laparoscopic
Musculo-skeletal
-Conventional-
Musculo-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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32

S2000 and S3000 Virtual Touch Imaging 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter for use with ACUSON S2000/3000 Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

| Clinical Application | 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+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} K130739

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