ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS

• K Number: K140959
• Device Name: ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2014-04-30 ( 15 days)
• Product Code: IYN ITX IYO OBJ
• Regulation Number: 892.1550

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 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 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 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.

Predicate Devices

K132804

Reference Devices

K123001, K081148, K09034, K093812, K111674, K121138

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device is described as a "diagnostic ultrasound system," and its intended use primarily involves imaging and measurement for diagnosis, not treatment.

Diagnostic

Yes
The "Device Description" section explicitly states, "The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems." The "Intended Use / Indications for Use" also mentions that the system provides "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states "The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems". This indicates the device includes hardware components (the ultrasound system itself) in addition to the software control.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Description: The description clearly states that this is an ultrasound imaging system. Ultrasound uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
• 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 diagnosis, the primary function is imaging, not in vitro testing.

Therefore, this device falls 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, 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 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.

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

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

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.

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

Indicated Patient Age Range

Adult and Pediatric (for Acuson Acunav Ultrasound Catheter), Not specified for general ultrasound applications.

Intended User / Care Setting

Physician / Not Found

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

Not Found

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

Not Found

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

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

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

Not Found

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

K132804

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.

K123001, K081148, K09034, K093812, K111674, K121138

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

510(k) Summary Prepared March 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.

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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
S1000/S2000
/S3000
This
Submission | Acuson
S1000/S2000
/S3000
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
S1000/S2000
/S3000
This
Submission | Acuson
S1000/S2000
/S3000
K# 132804 |
| 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 |
| 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.

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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

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

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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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric	N	N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Small Organ
(Note 1)	N	N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,
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,
11, 14
Laparoscopic
Musculo-skeletal
Conventional	N	N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,10,
11, 14
Musculo-skeletal
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)

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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
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# 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)

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510(k) K140959

Page 3 of 26

10

510 (k) Number (if K 140959 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 | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative
(Note 9) | | | | | P | | | | | |
| Intraoperative
Neurological | | | | | P | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | P | | | | | |
| Musculo-skeletal
Superficial | | | | | P | | | | | |
| Other (specify) | | | | | | | | | | |

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

.

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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
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 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,
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# 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)

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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
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 2,3,4,5,6,,7,8,10, 11, | | | |
| 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 | | | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,
11,14 | | | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

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

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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
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		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,
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#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)

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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
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
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 spalial compounding Note 3

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Abdomen and Vascular Note 9

technology

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

Power SieScape panoramic imaging Note 8 Clanfy VE vascular enhancement Note 10 Note 14 eSie™ Touch elasticity imaging / FTI Nole 18 Virtual Touch Imaging

Ensemble tissue hamonic imaging

Tissue Equalization Technology

Cadence contrast agent imaging

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

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K140059 510(k)

Page 7 of 26

S-Family 510(k) Submission

Note 2

Note 4

Nole 6

15

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

Device Name: ondad lice

4P1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative
Note 9 | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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

Power SieScape panoramic imaging Note 8

Abdomen and Vascular Note 9

Note 10 Clarify VE vascular enhancement technology

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

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510(k) K140959

Page 8 of 26

16

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):	K140959
Device Name:	6C2 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:
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
Note 9
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

....

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

• Tissue Equalization Technology Note 4
  Note 7 B&W SieScape panoramic imaging

Abdomen and Vascular Note 9

• Note 11 Advanced Sieclear spatial compounding
  Note 16 Custom Tissue Imaging

SieClear multi-view spatial compounding Note 3

3-Scape real-time 3D imaging Note 5

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Nota 17 eSie Fusion

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

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510(k)_K140959

Page 9 of 26 .

Labels	Values
THE
CITY
MAYOR

17

Device Name:

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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

4C1 Curved 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 Color Other Combined Color Amplitude Velocity Clinical Application PWD CWD A B M (Specify) (Specify) Doppler Doppler Imaging Ophthalmic BMDC Note 2,3,4,5,7,8,10, 11 P P P Felal P P P Note2,3,4,5,6,7,8, 10, BMDC P P P P P P Abdominal 11, 14, 16, 17, 18 Intraoperative Note 9 Intraoperative · Neurological Pediatric P P P P BMDC Small Organ P P Neonatal Cephalic Adult Cephalic P P P BMDC P P P Cardiac Trans-esophagea! Transrectal Transvaginal Transurethral Intravascular BMDC P P P P P P Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

Note 14 eSie™ Touch elasticity imaging / FT1

Note 17 eSie Fusion

SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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

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s10(k)_K140959

Page 10 of 26

S-Family 510(k) Submission

3-Scape real-time 3D imaging Note 5

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

• Note 16 Custom Tissue Imaging
  Note 18 VTI

Note 3 Note 7

18

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

6C1HD Curved Array Transducer For Use On ACUSON 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	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# 132804

Additional Comments:

• Note 2 Ensemble tissue harmonic imaging
• Tissue Equalization Technology Note 4
• 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
• Nole 17 eSie Fusion

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
• Advanced Sieclear spatial compounding Note 11
• Note 16 Custom Tissue Imaging
• Note 18 VTI

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

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510(k)_K140959

Page 11 of 26

19

Device Name:

Intended Use:

F

Diagnostic Ultrasound Indications for Use Form

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

8C3HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
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
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# 132804

Additional Comments:

Note 6

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4

SieClear multi-view spatial compounding Note 3 3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7 Note 14 eSie™ Touch elasticity imaging / FTI

Note 10 Clarify VE vascular enhancement technology

Cadence contrast agent imaging Power SieScape panoramic imaging Note 8 Advanced Sieclear spatial compounding

Note 11 Note 16 Custom Tissue Imaging

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

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510(k)_K140959

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20

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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

Intended Use:

4V1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Device Name: Ultrasound Systems

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10.
14, 16, 17
Intraoperative
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# 132804

Additional Comments:

Ensemble tissue harmonic imaging Note 2

• 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
• eSie Fusion Note 17

Note 3 SieClear multi view spatial compounding

3-Scape real-time 3D imaging Note 5

• Power SieScape panoramic imaging Note 8
• Note 11 Advanced Sieclear spatial compounding
• Note 16 Custom Tissue Imaging

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Page 13 of 26

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

Device Name:

10V4 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
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# 132804

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

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

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

| Device Name: | 14L5 SP Linear Array Transducer For Use On ACUSON S1000, S2000, S3000
Ultrasound Systems | | | | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|--|--|--|
| Indications For Use: | Diagnostic 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) | | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11 | | | |
| Intraoperative
Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14, 16 | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 15 | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note2,3,4,5,6
,7,8,10, 11,14,15 | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

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

• Note 7 B&W SieScape panoramic imaging

• For example: vascular, abdominal Note 9

• Advanced Sieclear spatial compounding Note 11

• Note 15 AHP

• Ensemble tissue harmonic imaging Note 2
  Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

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

• Note 10 Siem Touch elasticity imaging / FTI

• Note 16 Custom Tissue Imaging

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

Device Name:

Intended Use:

7CF2 Curved array mechanical 3D transducer For Use On ACUSON $1000, S2000, S3000 Ultrasound Systems

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
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# 132804

Additional Comments:

Ensemble tissue harmonic imaging Note 2

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

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement lechnology

Advanced Sieclear spatial compounding Note 11

Note 13 STIC

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24

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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

Device Name:

Intended Use:

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:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
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# 132804

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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510 (k) Number (if known): K140059

Device Name:

9EVF4 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		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 K# 132804

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 Nole 5

B&W SieScape panoramic Imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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510 (k) Number (if known):	K140959
Device Name:	V5Ms Multiplane 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:
	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# 132804

Additional Comments:

Note 4 Tissue Equalization Technology

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

Device Name:

18L6 HD 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:	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		BMDC	Note 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14
Other (specify)

N = new indication: P = previously cleared by FDA K081148, K09034, K093812, K111674, K121138

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

Power SieScape panoramic imaging Note 8

Advanced Sieclear spatial compounding Note 11

Note 15 AHP

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging

Note 16 Custom Tissue Imaging/FTI

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

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

Device Name:

8V3 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
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)		P	P	P	P	P	P		BMDC	Note 3,4,6

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

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

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

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K140959 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)
Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10

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

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

• Note 15 AHP

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S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

, 510 (k) Number (if known). K (40959

| Device Name: 6L3 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	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic									BMIX
Fetal	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10,
11
Abdominal
Intraoperative
Note 9	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10,
11
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10,
1
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10
15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10,
11 15
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10,
11
Musculo-skeletal
Superficial	P	P	P	P	P	P	P		BMIX	Note 2 3 4 5 7 8 10.
11
Other (specify)

N = new indication; P = previously cleared by FDA K# s132804

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4

Cadence contrast agent imaging Note 6

Power SieScape panoramic imaging Note 8

Advanced Sieclear spalial compounding Note 11

• 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 technology Note 15 AHP

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31

S-Family Ultrasound Systems 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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

Device Name:

EV8C4 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
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 6 7 8
10
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Note б Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

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

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S-Family Ultrasound Systems 510(k) Submission

510 (k) Number (if known):	K140959
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
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 #K132804

Additional Comments:

*Compinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, "Commanding mclude: B+M, B+FWD, B+CwD, B+Gold Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

Ensemble tissue harmonic imaging Note 2

Tissue Equalization Technology Note 4

Note 10 Clarify VE vascular enhancement technology

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

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510(k)_K140959

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

Device Name:

Intended Use:

AcuNav 8F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Uitrasound 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									P
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=Previously cleared by the FDA K132804

Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Calor Collonations methodor 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 a separate page if needed)

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

510(k) K140959

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Diagnostic Ultrasound Indications for Use Form

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

Device Name:

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

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

P=Previously cleared by the FDA K132804

Additional Comments:

Additions (Comments)
*Combinations include: B+M, B+CWD, B+Color Dopler, B+M+ Colo Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler.

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON 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

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