ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS

K140959 · Siemens Medical Solutions USA, Inc. · IYN · Apr 30, 2014 · Radiology

Device Facts

• Record ID: K140959
• Device Name: ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, 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 normative tables that have been validated in peerreviewed 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 lmaging". The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Device Story

Mobile, software-controlled diagnostic ultrasound systems; input via ultrasound transducers (array/catheter) capturing primary/secondary harmonic echo data. Transforms inputs into B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Amplitude Doppler, 3D/4D imaging. Used in clinical settings by physicians/technicians. Provides anatomical measurements and calculation packages (e.g., Arterial Health Package for Intima Media Thickness) to assist clinical diagnosis. Output displayed on flat panel monitor; includes thermal/mechanical indices. Benefits include non-invasive visualization of anatomy/physiology and adjunct data for cardiovascular risk assessment.

Clinical Evidence

Bench testing only. No clinical data required as the systems utilize the same technology and principles as existing cleared devices. Compliance verified through acoustic output, biocompatibility, and safety testing.

Technological Characteristics

Mobile ultrasound system; 21" FPD; supports multiple transducer types (curved, linear, phased array, TEE, catheter). Modes: B, M, PW/CW Doppler, Color/Amplitude Doppler, 3D/4D. Features: Tissue Harmonic Imaging, SieScape panoramic, 3-Scape, TEQ, Auto OB, spatial compounding, elasticity imaging (eSie Touch), VTI, AHP. Connectivity: Wireless. Patient contact materials tested to ISO 10993-1. Electrical safety: UL 60601-1, CSA C22.2 No. 601-1. Software-controlled.

Indications for Use

Indicated for fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications in adult and pediatric patients.

Regulatory Classification

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.

Predicate Devices

• S1000 (K132804)
• S2000 (K132804)
• S3000 (K132804)

Submission Summary (Full Text)

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

### 510(k) Summary Prepared March 4, 2014

APR 3 0 2014

- 1. Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
- Christine Dunn Contact Person: [phone] Telephone: Fax: [phone]
- Acuson S1000, S2000, S3000™ Diagnostic Ultrasound Systems 2. Device Name:
- Diagnostic Ultrasound System Common Name:

### Classification:

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

| 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 modified Acuson S1000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:

| System | 510(k) |
|--------|---------|
| S1000 | K132804 |
| S2000 | K132804 |
| S3000 | K132804 |

### 4. Device Description:

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function on borevire 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.

**Page 8 of 64**

pg 104

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

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, 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 normative tables that have been validated in peerreviewed 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 lmaging".

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

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

| Feature / Characteristic | Acuson<br>S1000/S2000<br>/S3000<br>This<br>Submission | Acuson<br>S1000/S2000<br>/S3000<br>K# 132804 |
|----------------------------------------------|-------------------------------------------------------|----------------------------------------------|
| 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 S1000/S2000 /S3000 K# 132804 |
| 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<br>S1000/S2000<br>/S3000<br>This<br>Submission | Acuson<br>S1000/S2000<br>/S3000<br>K# 132804 |
| VTI (S2000 & S3000 only) | √ | √ |
| Wireless | √ | √ |
| Monitor: 21" FPD | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO<br>10993-1 | Tested to<br>ISO 10993-1 |
| UL 60601-1 Certified | √ | √ |
| Indications for Use | √ | √ |

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

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

## 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, 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 l
- JEC 60601-2-37 Diagnostic Ultrasound Safety Standards l
- CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment 트
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output 트 Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound l
- 93/42/EEC Medical Devices Directive ●
- Safety and EMC Requirements for Medical Equipment l
- EN/IEC 60601-1 D
- EN/IEC 60601-1-1 트
- EN/IEC 60601-1-2 l
- . 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.

### 8. 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 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.

Page 11 of 64

pg 4 8 4

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol in the center consists of three stylized, curved lines that resemble a person with outstretched arms.

Public Health Service

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

April 30, 2014

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

Re: K140959

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: IYN, IYO, ITX, OBJ Dated: April 14, 2014 Received: April 15, 2014

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 Systems, as described in your premarket notification:

Transducer Model Number

12LA EC9-4 Curved Array 14L5 Multi-D Array 4C1 Curved Array 4VI Phased Array 9EVF4 Curved Array Array8V3 Phased Array EV8C4 7CF2 Curved array mechanical 3D AcuNav 8F Ultrasound Catheter

CW2 Probe MC9-4 Curved Array 4P1 Phased Array 6C1HD Curved Array 10V4 Phased Array V5Ms Multiplane TEE 4V1c Phased Array V7M TEE

CW5 Probe 9LA Linear Array 6C2 Curved Array 8C3HD Curved Array 14L5 SP Linear Array 18L6 HD Linear ୧୮3

7CF1 Curved array mechanical 3D AcuNav 10F Ultrasound Catheter

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

Page 2-Mr. Job

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.p)

for

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

Enclosure

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

#### 1.3 Indications for Use

### A. 510(k) Number (if known): K140959

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

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac r readon't see 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)

AND/OR

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Smm.7)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

K140959 510(k)__

Page 1 of 26

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

### 1.3 Indications for Use Forms

Device Name:

## Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): K 140959

### ACUSON S1000, S2000, S3000 Ultrasound System

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | P | P | P | P | P | P | P | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 16, 18 |
| Intraoperative<br>(Note 9) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 16, 18 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | P | P | P | P | P | P | P | | BMDC | Note 4 |
| Transrectal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Transvaginal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,10,<br>11,14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 18 |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11.14. 18 |
| Other (specify)<br>Neonatal Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4,6, 10 |

N = new indication; P = previously cleared by FDA K 132804

l.e. breast, testes, thyrold, penis, prostate, etc. Note 1 Tissue Equalization Technology

B&W SieScape panoramic Imaging

Note 2 Ensemble tissue harmonic imaging
Note 5 3-Scape real-time 3D imaging

Note 8 Power SieScape panoramic imaging Note 11 Advanced Sisclear spatial compounding

Real-time 3D imaging
Scape panoramic imaging
Note 8: Option
Note 9: For

Note 3 SieClear multi-vlew spatial compounding Note 6 Cadence contrast agent imaging Note 9 For example: vascular, abdominal

Note 13 STIC Note 16 Custom Tissue Imaging

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

Note 14 eSle Fusion

Note 17 VTI Note 18

Note 4

Nota 7

(Please do not write below this line-continue on a separate page if needed)

Concurrence of Center for Devices and Radiological Health (CDRH)

Note 15 AHP

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 240(k)K140959

Page 2 of 26

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

510 (k) Number (if known): K | 40959

Device Name: Intended Use: 12L4 Transducer for use with ACUSON S1000, S2000 and S3000 Ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | N | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Small Organ<br>(Note 1) | N | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | Note 2,3,4,5, 7,8,10, |
| Peripheral vessel | N | N | N | N | | N | N | | BMDC | Note 2,3,4,5, 7,8,10,<br>11, 14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | N | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication P = previously cleared by FDA K123001

Additional Comments:

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

3-Scape real-time 3D imaging Note 5

- B&W SieScape panoramic imaging Note 7
Note 10 Clarify VE vascular enhancement fechnology

compounding/DTCE

Note 14 eSie™ Touch elasticity imaging

- 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

Note 16 Custom Tissue Imaging /FTI

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

540(k) K140059 ---------------------------------------------------------------------------------------------------------------------------------------------------------------

Page 2 of 26

Page 2 of

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

### S-Family Ultrasound Systems 510(k) Submission

## Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): K | 40959

| Device Name: | CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System | | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | P | | | | | | | |
| Abdominal | | | | | P | | | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | P | | | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | | | |
| Neonatal Cephalic | | | | | P | | | | | | | |
| Adult Cephalic | | | | | P | | | | | | | |
| Cardiac | | | | | P | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 132804

Additional Comments:

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

For example: vascular, abdominal Note 9

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k) K140959

Page 3 of 26

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

510 (k) Number (if K 140959 known).

| Device Name:<br>Intended Use: | CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | P | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K#132804

Additional Comments:

For example: breast, testes, thyroid, penis, prostale, etc. For example: vascular, abdominal Note 9 Nole 1

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

.

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K140959

Page 4 of 26

l Health (CDPH)

vices and Radiological Health (CDRH)

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

510 (k) Number (if known): K | 40959

EC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Device Name: System 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(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, 11 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,<br>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<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 132804

Additional Comments:

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

SieClear multi-view spatial compounding Note 3

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Advanced Sieclear spatial compounding Note 11

eSie™ Touch elasticity imaging / FTI Note 14

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Nole 4

Note 6 Cadence contrast agent imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

(Please do not write below this line-continue on a separate page if needed)

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K140959

Page 5 of 26

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

### S-Family Ultrasound Systems 510(k) Submission

### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): K I 40959

| Device Name: | MC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>Note 9 | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ<br>(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,<br>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<br>Conventional | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K# 132804

Additional Comments:

- For example: breast, testes, thyroid, penis, prostate, etc Note 1
SieClear multi-view spatial compounding Note 3

- 3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7

- Abdomen and Vascular Note 9
Note 11 Advanced Sieclear spatial compounding

Ensemble tissue harmonic imaging Nole 2

Tissue Equalization Technology Nole 4

Cadence contrast agent imaging Note 6

- Power SieScape panoramic imaging Note 8
- Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

K140959 510(k)_

S-Family 510(k) Submission

ging

pounding
(PLEASE DO NOT WRITE BELOW THIS LINE)

Page 6 of 26

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

T

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): K I 40959

Device Name:

9L4 Linear Array 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,14,<br>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 | | BMDC | |
| 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,<br>14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 |
| Musculo-skeletal<br>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#132804

Additional Comments:

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

SieClear multi-view spatial compounding Note 3

Note 2 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Abdomen and Vascular Note 9

Advanced Sieclear spalial compounding Nole 11

Nole 15 AHP

Note 18 VTI (Virtual Touch Imaging)

- Ensemble lissue hamonic imaging Note 2
- Tissue Equalization Technology Nole 4
- Cadence contrast agent imaging

Power SieScape panoramic imaging Clarify VE vascular enhancement technology

Note 10 Clarity VE vascular enhancement technique
Note 11. Shear Wave Touch elasticity imaging (ETI)

- Note 14
-

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K140959

Page 6 of 26

S-Family 510(k) Submission

Nole 6 Nole 8

> Note 10 eSie™ Touch elasticity imaging / FTI

- Custom Tissue Imaging Note 16
-

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

Device Name:

Intended Use:

### S-Family Ultrasound Systems 510(k) Submission

#### Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): K l 40959

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

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | |…