Predicate Devices

K130619, K123622, K123001, K130739, K112596, K121138

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". The description focuses on standard ultrasound imaging modes and measurement packages, with no indication of AI/ML capabilities.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states that the device is for "clinical diagnosis purposes" and provides "information to the clinician that may be used adjunctively with other medical data... for clinical diagnosis purposes." It is described as a "diagnostic ultrasound system," indicating its role in identifying medical conditions rather than treating them.

Diagnostic

Yes

Explanation: The "Device Description" explicitly states that the ultrasound systems are "diagnostic ultrasound systems." Additionally, the "Intended Use / Indications for Use" section mentions that the system's 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 "software controlled diagnostic ultrasound system" and describes hardware components like transducers (implied by ultrasound echo data acquisition) and a Flat Panel Display. It also mentions an "Acuson Acunav Ultrasound Catheter," which is a hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
Device Function: The description clearly states that this is an ultrasound imaging system. Ultrasound is a non-invasive imaging modality that uses sound waves to create images of internal body structures. It does not involve the examination of specimens in vitro.
Intended Use: The intended uses listed are all related to imaging and visualization of anatomical structures within the body. While the system provides measurements and calculations that can be used adjunctively with other medical data for clinical diagnosis, the primary function is imaging, not the analysis of biological specimens outside the body.
Arterial Health Package (AHP): Even the AHP, which measures Intima Media Thickness, does so through ultrasound imaging of the carotid artery in vivo, not by analyzing a blood sample or other specimen in vitro.

Therefore, the device's function and intended use fall under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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, pediatric, small organ, neonatal cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and calculation packages 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 gublished in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with palients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

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

90-IYN, 90-IYC, 90-ITX, OBJ

Device Description

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and onscreen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-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.

Mentions image processing

Not Found

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, Adult, Intra-cardiac, Intra-luminal visualization of cardiac and great vessel anatomy and physiology

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

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)

Not Found

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.

K130619, K123622, K123001, K130739, K112596, 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.

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

K132804
page 1 of 5

S-Family Ultrasound Systems 510(k) Submission

510(k) Summary Prepared July 18, 2013

| 1. Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 | | OCT 2 4 2013 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------|
| Contact Person: | Christine Dunn
Telephone:
Fax: | (425) 785-1617
(425) 391-9161 | |
| 2. Device Name: | Acuson S1000, S2000, 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-IYC
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 modified Acuson S1000, S2000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:

System	510(k)
S1000	K130619; K123622; K123001
S2000	K130739; K112596; K123622; K123001
S3000	K130739; K121138; K123622; K123001

4. Device Description:

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and onscreen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-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.

5. Intended Use

The 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

Siemens Medical Solutions, Inc.	S-Family Ultrasound Systems
Ultrasound Division	510(k) Submission

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, cardiac, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages 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 normalive 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 Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

1986年 1986 - 1987 - 1987 - 1987 - 1987 - 1987 - 1998 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991

| | Feature / Characteristic | Acuson
S1000/S2000
/S3000
This
Submission | Acuson
SC2000
K123622 | Acuson
S1000
K130619 | Acuson
S2000
K112596 | Acuson
S2000
K130739 | Acuson
S3000
K121138 | Acuson
S3000
K130739 |
|---------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------|----------------------------|----------------------------|----------------------------|----------------------------|----------------------------|
| | Indications for Use: | | | | | | | |
| | Fetal | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | Abdominal | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | Intraoperative | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 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 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 3.3 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 4.2 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| | 4.4 MHz | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Feature / Characteristic | Acuson
S1000/S2000
/S3000
This
Submission | Acuson
SC2000
K123622 | Acuson
S1000
K130619 | Acuson
S2000
K112596 | Acuson
S2000
K130739 | Acuson
S3000
K121138 | Acuson
S3000
K130739 | |
| 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 | √ | √ | √ | √ | √ | √ | √ | |
| 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) | √ | √ | √ | √ | √ | √ | √ | |
| Custom Tissue Imaging / Speed of
Sound | √ | √ | √ | √ | √ | √ | √ | |
| •
AHP | √ | √ | √ | √ | √ | √ | √ | |
| Feature / Characteristic | Acuson
S1000/S2000
/S3000
This
Submission | Acuson
SC2000
K123622 | Acuson
S1000
K130619 | Acuson
S2000
K112596 | Acuson
S2000
K130739 | Acuson
S3000
K121138 | Acuson
S3000
K130739 | |
| • VTI (S2000 & S3000 only) | √ | | | | √ | | √ | |
| Wireless | √ | √ | √ | | | | | |
| Monitor: 21' 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 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | |
| UL 60601-1 Certified | √ | √ | √ | √ | √ | √ | √ | |
| Indications for Use | √ | √ | √ | √ | √ | √ | √ | |

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

2

S-Family Ultrasound Systems 510(k) Submission

S-Family 510(k) Submission

Page 10 of 64

3

S-Family Ultrasound Systems 510(k) Submission

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

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic 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 이
트 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 l
Safety and EMC Requirements for Medical Equipment I
- 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.

Additional testing was performed to verify the software release as well as transducer and wireless performance.

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

Since the S1000, S2000, S3000 systems use the same technology and principles as existing devices, clinical data is not required.

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 to 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

4

K132804
Page 5 of 5

S-Family Ultrasound Systems 510(k) Submission

of Siemens Medical that the S1000, S2000 and S3000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. .

S-Family 510(k) Submission

.

·

Page 12 of 64

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 features the department's seal, which includes an emblem of an eagle with three bars on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Public Health Service

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

October 24, 2013

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

Re: K132804

Trade/Device Name: Acuson S1000/ S2000/ 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 and OBJ Dated: October 9, 2013 Received: October 10, 2013

Dear Mr. Job:

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 S1000/S3000 Diagnostic Ultrasound System, as described in your premarket notification:

	Transducer Model Number
CW2	CWS	EC9-4
MC9-4	91_4	141.5
4	6C2	4CI
RCIFID	8C3HD	4V
10V4	141.5 SP	7CF2
7CF1	9EVF4	V SMs
18L6	8V3	4V lc
613	EV8C4	V7M TEE
AcuNav 8F	AcuNav 10F

6

Page 2-Mr. Job

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 clectronic 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.lda.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.lda.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 vours.

Smhif)

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

K132804 A. 510(k) Number (if known):

Device Name: S1000, S2000, S3000 Diagnostic Ultrasound Systems

Indications for Use:

The 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, pediatric, small organ, neonatal cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and calculation packages 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 gublished in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with palients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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.

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

AND/OR

(min. 77)

.

Division Sign-Off Division of Radiological Health; Office of In Vitro Diagnostics and Radiological Health

K132804 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 16 of 64

8

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

ACUSON S1000, S2000, S3000 Ultrasound System 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
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13, 16, 18
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		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
Small Organ
(Note 1)		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	BMDC	Note 2,3,4,5,7,8,10
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
2,3,4,5,6,7,8,10,15
Trans-esophageal		P	P	P	P	P	P	BMDC	Note 4
Transrectal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11.14
Transvaginal		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	BMDC	Note 2,3,4,5,6,7,8,10,
11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11.14, 18
Musculo-skeletal
Superficial		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 18
Other (specify)		P	P	P	P	P	P	BMDC	Note 3,4,6, 10

N = new natalian, P = previously classed by FDA K032142, K03034, K09302, K111674, K112556, K12113, K123001, K120615, K12136 K12302, K12053

Nole 1 e breast, testes thyroid penis, prostate etc

Nole 7

Clarity VE vascular ennancoment technology
eSæ ™ Touch elasticity imaging / FTI Nole 10

Nole 14

Note 17 e Sie Fusion

Note 18 VTI

A

Note 2 Ensamble tissue harmonic imaging Note 5 3-Scape real-time 3D imaging Note 8 Power SieScape panoramic imaging Note 11 Advanced Sieclear spatial compounding Note 15 AHP

Note 3 SieClear mulli-view spatial compounding Note 6 Cadence contrast agent imaging Note 9 For example vascular, abdominal Note 13 STIC

Note 16 Custom Tissue Imaging

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Page 17 of 64

Tissue Equa ization Technology
B&W SieScape panoramic imaging Note 4

9

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (il known):

Device Name: Intended Use:

CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System 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# 063803, K072786, K090334, , K093812, K111674, K121138

Additional Comments:

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

Note 9 For example: vascular, abdominal

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10

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Color Amplitude Combined Other PWD CWD Clinical Application A B M Velocity Doppler Doppler (Specify) (Specify) Imaging Oph:halmic P Fetal P Abdomina! Intraoperative P (Note 9) Intraoperative P Neurological P Pediatric Small Organ P (Note 1) P Neonatal Cephalic Adult Cephalic P P Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular P Peripheral vessel Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal P Superficial Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K090334 , K093812, K111674, K121138

Additional Comments:

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

Note 9 For example vascular, abdominat

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11

510 (k) Number (if known):

Device Name:

EC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systom

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
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cepnalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,11
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# 063803, K072786, K090334, K093812, K111674, K121138

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Nole 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

Note B Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Advanced Sieclear spatial compounding Note 11

Note 14 eSie™ Touch elasticity imaging / FTI

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

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12

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

MC9-4 Curved Array Transducer For Uso On ACUSON S1000, 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
Fetal		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal		N	N	N		N	N	BMDC	Note 2,3,4,5,6,7,8,10, 11
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cephalic		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		N	N	N		N	N	BMDC	Note 2,3,4,5, 6, 7,8,10,
11,14
Transvaginal		N	N	N		N	N	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# 063803, K072786, K09034, K093812, K111674, K121138, K123001

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

Note 4 Tissue Equalization Technology

Note 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note B

Note 9 Abdomen and Vascular

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie 14 Touch elasticity imaging / FT1

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510(k) =======================================================================================================================================================================

S-Family 510(k) Submission

Page 21 of 64

Page 6 of

13

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

For Use On ACUSON S1000, S2000, S3000

Device Name:

	9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S30
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
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal
Intraoperative
Note 9
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
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Other (specify)

N = new indication: P = previously cleared by FDA K# 053085, K072786, K081148, K093812, K111674, K121138, K130739

Additional Comments:

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 Nole 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial compounding
Note 15 AHP

Note 18 VTI (Virtual Touch Imaging)

Nole 2 Ensemble tissue harmonic imaging Tissue Equalization Technology Note 4
Note 6 Cadence contrast agent imaging Power SieScape panoramic imaging Note B
Note 10
Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

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

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510(k)_

Page 6 of _

S-Family 510(k) Submission

Page 22 of 64

e In Vitro Diagnostics and Radiological

14

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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
Note 9
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

N = new indication; P = previously cleared by FDA K# 063085, K072788, K080334, K093812, K111674, K121138

Additional Comments:

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

Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular

Nole 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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510fk)_

.

S-Family 510(k) Submission

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology
Ensemble tissue harmonic imaging
Note 14 eSie™ Touch elasticity imaging / FTI
Note 18 Virtual Touch Imaging

Note 2

15

510 (k) Number (if known):

Device Name:

4P1 Phased Array Transducer For Use On ACUSON S1000, 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
	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
Note 9
	Intraoperative
Neurological
	Pediatric
	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 2,3,4,5,6,7,8,10
	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# 063803, K072786, K081148, K090334, K093812, K111674, K121138

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note O Abdomen and Vascular

Note 10 Clarify VE vascular enhancement technology

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Page 8 ot _

S-Family 510(k) Submission

Page 24 of 64

16

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

6C2 Curved Array Transducer For Use On ACUSON $1000, 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
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, 17
Intraoperative
Nore g
Intraoperative
Neurologica!
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	ក្រ	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# 063085, K072786, K08142, K090334, K111674, K121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4

B&W SieScape panoramic imaging Note 7

Note 9 Abdomen and Vascular
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 2
Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion

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

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Division Sign-Off Division of Radiological Health; Office of In Vitro Diagnostics and Radiological Health

510(k)

Page 9 ol _

17

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

4C1 Curved Array Transducer For Use On ACUSON S1000, 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
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, 18
Intraoperative
Note 9
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 KA 063085, K072786, K081148, K093812, K111674, K121138, K130739

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Cadence contrast agent imaging Note 6
Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

eSie™ Touch elasticity imaging / FTI Note 14
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
3 Scape real-time 3D imaging Note 5
- B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial compounding

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

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S-Family 510(k) Submission

Page 26 of 64

Page 10 ot _

Note 7
Note 16 Custom Tissue Imaging
Note 18 VTI

18

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

6C1HD Curved Array Transducer For Use On 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
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,
18
Intraoperative
Note 9
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, K121138, K130739

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
Clarify VE vascular enhancement technology Note 10 eSie™ Touch elasticity imaging / FTI
Note 14
Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging
Note 18 VTI

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

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Division Sign-Off Division of Radiological Health: Office of In Vitro Diagnostics and Radiological Health

510(k)_

.

Page 11 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 27 of 64

19

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

8C3HD Curved Array Transducer For Use On ACUSON S2000, $3000 Ultrasound Systems

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

Device Name: Intended Use:

| 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
Note 9 | | | | | | | | | | |

| Intraoperative

Note 9
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. K#130739

Additional Comments

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Cadence contrast agent imaging Note 6

Note 16 Custom Tissue Imaging

Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear 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 efasticity imaging / FTI

SieClear multi-view spatial compounding

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

Nole 3

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Division Sign-Off Division of Radiological Health; Office of In Vitro Diagnosiics and Radiological Health

510(k)_

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S-Family 510(k) Submission

Page 28 of 64

20 - 5.0

20

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

4V1 Phased Array Transducer For Use On ACUSON S1000, 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
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,

1. 17 |
  | Intraoperative | | | | | | | | | | |
  | Intraoperative
  Neurological | | | | | | | | | | |
  | Pediatric | | | | | | | | | | |
  | Small Organ | | | | | | | | | | |
  | Neonatal Cephalic | | | | | | | | | | |
  | Adult Cephalic | | | | | | | | | | |
  | Cardiac | | | | | | | | | | |
  | Trans-esophageal | | | | | | | | | | |
  | Transrectal | | | | | | | | | | |
  | Transvaginal | | | | | | | | | | |
  | Transurethrai | | | | | | | | | | |
  | Intravascular | | | | | | | | | | |
  | Peripheral vessel | | | | | | | | | | |
  | Laparoscopic | | | | | | | | | | |
  | Musculo-skeletal
  Conventional | | | | | | | | | | |
  | Musculo-skeletal
  Superficial | | | | | | | | | | |
  | Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 063085, K072786, K092142, K090334, K111674, K121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
B&W SieScape panoramic imaging Note 7
Clarify VE vascular enhancement technology Note 10
Note 14 eSie™ Touch elasticity imaging / FTI
Note 3 SieClear multi view spatial compounding 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

Note 17 eSie Fusion

(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)

510(k)_

Page 13 of ___________________________________________________________________________________________________________________________________________________________________

Division Sign-Off Division of Radiological Health; Office of In Viro Diagnostics and Radiological Health

21

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

10V4 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Device Name: Intended Use:

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

Intended Use:

	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
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)

N = new indication, P = previously cleared by FDA K# 063085, K072786, K081148, K092812, K111674, K121138

Additional Comments

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Nole 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

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

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510(k)_

Page 14 of

22

510 (k) Number (if known):

14L5 SP Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Device Name: Ultrasound Systems Indications For Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal Intraoperative Note P p P P P BMDC (Note 9) 2.3.4.5.7.8.10.11 Intraoperative Neurological Pediatric Small Organ Note 2,3,4,5,7,8,10, P P ర్లు P P BMDC (Note 1) 11,14, 16 Neonatal Cephalic Adult Cephalic p P Cardiac P P 0. BMDC Note 15 Transesophageal Transrectal Transvaginal Transurethral Intravascular Note2,3,4,5,6 Peripheral vessel P P P b P BMDC 7.8.10, 11,14,15 Laparoscopic Musculo-skeietai Note 2,3,4,5,7,8,10, p P P p P BMDC Conventional 11.14 Musculo-skeletal -Superficial Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K08142, K09034, K111674, K121138

Additional Comments:

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 Sieclear spatial compounding

Note 15 AHP

te 15 AHP

Note 2 Ensemble tissue harmonic imaging Tissue Equalization Technology Note 4 Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI

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

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510(k)

Page 15 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 31 of 64

Note 16 Custom Tissue Imaging

IPLEASE DO NOT WRITE BELOW THIS LINE.CONTINUE ON ANOTHER PAGE IF NEEDED)

23

.

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

7CF2 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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,

13 |
| Intraoperative | | | | | | | | | | |
| 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# 063803, K072786, K08142, K090334, K111674, K121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

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

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

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51D(k)________________________________________________________________________________________________________________________________________________________________________

Page 16 o! ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 32 of 64

24

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Uitrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

7CF1 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11.13
Abdominal		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
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# 063803, K072786, K081148, K090334, K111874, K121138

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

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

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

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510(k)

Page 15 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 33 of 64

25

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known);

9EVF4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

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
Intraoperative
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 X# 063803, K072786, K09142, K090334, K111674, K121138

Additional Comments

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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

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Division Sign-Off Division of Radiological Health; Office of In Viro Diagnostics and Radiological Health

510(k)_

Page 17 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 34 of 64

26

510 (k) Number (if known):

Device Name:

V5Ms Multiplane TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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
	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# 063803, K072786, K081148, K082812, K111674, K121138

Additional Comments:

Note 4 Tissue Equalization Technology

(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)

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.

510(k)_

Page 18 01 ___________________________________________________________________________________________________________________________________________________________________

27

510 (k) Number (if known):

Device Name:

. •

18L6 HD Lincar Array Transducer For Use On ACUSON $1000, 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
	Fetal
	Abdominal
	Intraoperative
	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	P		BMDC	Note 15
	Trans-esophageal
	Transrectal
	Transvaginal
	Transurethral
	Intravascular
	Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14,15
	Laparoscopic
	Musculo-skeletal
Conventional	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7.8.10.
11.14
	Musculo-skeletal
Superficial	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11.14
	Other (specify)

N = new indication; P = previously cleared by FDA K081148, K080334, K093812, K111674, K121138

Additional Comments

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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Nole 4 Tissue Equalization Technology

Note 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

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

(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)

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510(k)________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Page 19 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 36 of 64

Note 15 AHP
Note 16 Custom Tissue Imaging

28

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

8V3 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Uitrasound Systems

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	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
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 indicalion; P = previously cleared by FDA K# 063085, K072786, K081148, K082112, K111674, K121138

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

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510(k)________________________________________________________________________________________________________________________________________________________________________

Page 20 ol ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 37 of 64

29

510 (k) Number (if known):

Device Name:

4V1c Phased Array Transducer For Use On ACUSON S1000, 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
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		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Neurological		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
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
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
15
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10

N = new indication, P = previously cleared by FDA K# : 052410, 051139, 041319, 132114, 022567, (6130834, K093812, K111674, K121138

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note ર 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

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

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

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Division Sign-Off Division of Radiological Heath; Office of In Vitro Diagnostics and Radiological Health

510(k)_

Page 21 of ___________________________________________________________________________________________________________________________________________________________________

30

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

6L3 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems Device Name: Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

		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
Note 9		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11
Intraoperative
Neurological
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# x 052410, 031139, 03111, 022567, 002807, 973767, 063085, K093812, K111674. K121138

Additional Comments

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

Cadence contrast agent imaging Note 6

Power SieScape panoramic imaging Note 8

Note 11 Advanced Sieclear spatial compounding

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 15 AHP

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

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Division Sign-Off Division of Radiological Heath: Office of In Vitro Diagnostics and Radiological Health

510(k)_

Page 22 of _____

S-Family 510(k) Submission

Page 39 of 64

31

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

EV8C4 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound

Device Name: Intended Use:

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

Intended Use:

	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
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 \ # s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812 , K111674. K121138

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

Cadence contrast agent imaging Nole 6

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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

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Division Sign-Off Division of Radiological Health; Office of In Vitro Diagnostics and Radiological Health

510(k)_

Page 23 of _

S-Family 510(k) Submission

Page 40 of 64

32

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

V7M TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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 | | | | | | | | | | | |
| 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 #K051139, #K041319, #K032114, and #K022567, K093812, K111674, K121138

Additional Comments:

*Combinations include: B+M, B+PWD, 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+Clarily VE

Ensemble tissue harmonic imaging Note 2

Note 4 Tissue Equalization Technology

Note 10 Clarify VE vascular enhancement technology

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

Division Sign-Off Division of Radiological Health; Office of in Viro Diagnostics and Radiological Health

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510 (k) Number (if known):

AcuNav 8F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Device Name: Ultrasound Systems Intended Use: 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 |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|
| 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 K992631. K033650, K042593. K071234. K093812. K111674. K121138

Additional Comments:

*Combinations include B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PW1)+Color Doppler, B+C'W1)+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)_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Page 25 പ ____________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

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AcuNav 10F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000

510 (k) Number (if known):

Device Name:

Intended Use:

Ultrasound Systems 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-l.uminal		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 K992631. K033650. K071234. K093812. K111674. K121138

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Br.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 Diagnosucs and Radiological Health

510(k)_

Page 25 of ___________________________________________________________________________________________________________________________________________________________________

S-Family 510(k) Submission

Page 43 of 64