ACUSON

• K Number: K111674
• Device Name: ACUSON
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2011-06-30 ( 15 days)
• Product Code: IYN ITX IYO OBJ
• Regulation Number: 892.1550

Intended Use

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrsound 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 S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

Predicate Devices

K093812, K090334, K072786, K081148, K063085, K071234, K063803

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with various imaging modes and measurement packages. There is no mention of AI, ML, deep learning, or any related terms in the intended use, device description, or other sections. The performance studies section explicitly states that clinical data is not required because the device uses the same technology and principles as existing devices, which is typical for non-AI/ML devices.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" and its intended use is for "clinical diagnosis purposes" or "visualization," not for treating or preventing disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states 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." Additionally, the "Device Description" section refers to the system as a "software controlled diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and describes hardware components like transducers (implied by ultrasound echo data acquisition) and a Flat Panel Display. While software is a key component, it is controlling hardware to acquire and display data.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The S2000™ Ultrasound System is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze samples taken from the body.
• Intended Use: The intended uses listed are all related to imaging and measuring anatomical structures within the body.
• Device Description: The description details how the system acquires and displays ultrasound echo data.
• Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.

Therefore, the S2000™ Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood fool for communicating with patients reqarding 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 Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

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

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

Device Description

The S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

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, Intraoperative neurological, Small Organ (e.g. breast, testes, thyroid, penis, prostate), Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Neonatal Cardiac. For the Acuson Acunav Ultrasound Catheter: Intra-cardiac and Intra-luminal (cardiac and great vessel anatomy).

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, Adult

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 S2000 uses 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.

K093812, K090334, K072786, K081148, K063085, K071234, K063803

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

K111674

JUN 3 0 2011

Siemens Medical Solutions, Inc. Ultrasound Division

S2000 Ultrasound System 510(k) Submission . .

510(k) Summarv Prepared May 12, 2011

| 1. Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 |
|------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shelly Pearce
Telephone: [phone]
Fax: [phone] |
| Submission Date: | May 12, 2011 |
| 2. Device Name: | Acuson S2000™ Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System |

Classification:

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

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
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 S2000™Ultrasound System is substantially equivalent to the the company's own Acuson Antares and S2000 Ultrasound Systems.

4. Device Description:

The S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K093812, K090334, K072786, K081148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 10F (K071234) transducers. These predicates are legally marketed devices.

5. Intended Use

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

1

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

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

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

| | Feature / Characteristic | Acuson
S2000 | Acuson
Antares
K# 063803 |
|---|------------------------------------------|-----------------|--------------------------------|
| | Indications for Use: | | |
| ■ | Fetal | √ | √ |
| ■ | Abdominal | √ | √ |
| ■ | Intraoperative abdominal and
vascular | √ | √ |
| ■ | Intraoperative neurological | - | - |
| ■ | Pediatric | √ | √ |
| ■ | Small Organ | √ | √ |
| ■ | Neonatal cephalic | √ | √ |
| ■ | Adult Cephalic | √ | √ |
| ■ | Cardiac | √ | √ |
| ■ | Trans-esophageal | √ | √ |
| ■ | Transrectal | √ | √ |
| ■ | Transvaginal | √ | √ |
| ■ | Peripheral vessel | √ | √ |
| ■ | Laparoscopic | - | - |
| ■ | Musculo-skeletal (conventional) | √ | √ |
| ■ | Musculo-skeletal (superficial) | √ | √ |
| | Center Frequencies Supported: | | |
| ■ | 2.0 MHz | √ | √ |
| ■ | 3.0 MHz | √ | √ |
| ■ | 3.2 MHz | √ | √ |
| ■ | 3.3 MHz | √ | √ |

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

2

S2000 Ultrasound System 510(k) Submission

| Feature / Characteristic | Acuson
S2000 | Acuson
Antares
K# 063803 |
|-----------------------------------|--------------------------|--------------------------------|
| 4.2 MHz | √ | √ |
| 4.4 MHz | √ | √ |
| 4.8 MHz | √ | - |
| 5.0 MHz | √ | √ |
| 5.2 MHz | √ | √ |
| 6.0 MHz | √ | √ |
| 6.5 MHz | √ | √ |
| 6.9 MHz | √ | √ |
| 9.5 MHz | √ | √ |
| 10.0 MHz | √ | - |
| Modes: | | |
| B | √ | √ |
| Parallel processing in B mode | √ | √ |
| M | √ | √ |
| PWD (Pulsed Wave Doppler) | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ |
| D (Color Doppler) | √ | √ |
| Amplitude Doppler | √ | √ |
| Combined (BMDC) | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 |
| UL 60601-1 Certified | √ | √ |

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

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and 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 D
• I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment

• AIUM/NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound

• . 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment .
  • =
  • EN/IEC 60601-1-1 .
  • EN/IEC 60601-1-2 .
• . IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

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

3

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

Since the S2000 uses 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 with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the S2000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

Re: K111674

Trade/Device Name: S2000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and OBJ Dated: June 14, 2011 Received: June 15, 2011

JUN 3 0 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

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

Transducer Model Number

CW2 CWS EC9-4 Curved Array 91_4 Linear Array 14L5 Multi-D Array 14L5BV Multi-D Array 4P1 Phased Array 6C2 Curved Array 4C1 Curved Array

6C1HD Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 17LSHDS Linear Array 18L6 HD Linear Array

5

8V3 Phased Array	V7M TEE
4V1c Phased Array	AcuNav 8F Ultrasound Catheter
6L3	AcuNav 10F Ultrasound Catheter
EV9C4

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

6

1.3 Indications for Use

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

Device Name: S2000™Diagnostic Ultrasound System

Indications for Use:

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

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

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood fool for communicating with patients reqarding 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 Ultrsound 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.

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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 1674

Page 1 of

S2000 510(k) Submission

Page 14 of 55

7

S2000 Ultrasound System 510(k) Submission

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

ACUSON S2000 Ultrasound System

Intended Use:

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

Mode of Operation Color Color Amplitude Other Combined PWD Clinical Application A B M CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11, 13 P p P P P P Note 2,3,4,5,7,8,10, Abdominal BMDC 11, 13, 16 P p P P P P Intraoperative Note 2,3,4,5,7,8,10, BMDC (Note 9) 11, 14 Intraoperative P P P P P Note 2,3,4,5,7,8,10, BMDC Neurological 11. 14 P p P P P Note 2,3,4,5,7,8,10, P Pediatric BMDC 11 P P Small Organ P P P P Note 2,3,4,5,7,8,10, BMDC (Note 1) 11,14, 16 P P P P P Neonatal Cephalic P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic P P P p P P BMDC Note 2,3,4,5,7,8,10 P P P P P P Note Cardiac BMDC 2.3.4.5.6.7.8.10,15 P P P P P P Trans-esophageal BMDC Note 4 P ロ P P Note 2,3,4,5,7,8,10, P Transrectal BMDC 11.14 P P P P Note 2,3,4,5,7,8,10, P Transvaginal BMDC 11 Transurethral Intravascular P P P Note2,3,4,5,6,7,8,10, P P P Perioheral vessel BMDC 11,14,15 Laparoscopic Musculo-skeletal P P P P P P Note 2,3,4,5,7,8,10, BMDC Conventional 11,14 Musculo-skeletal P P P P Note 2,3,4,5,7,8,10, P p BMDC Superficial 11,14 Other (specify) P P P P P P Note 3,4,6, 10 BMDC Neonatal Cardiac

N = new Indication: P = previously cleared by FDA K063085, K063803, K072786, K081148, K082812

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

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

Note 9 For example: vascular, abdominal

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

• Note 16 Custom Tissue Imaging
  Note 2 Ensemble tissue harmonic imaging Note 4 Tissue Equalization Technology . Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 13 STIC Note 15 AHP

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Part 21CFR 801 Subpart D)

Mary Stade

510K

S2000 510(k) Submission

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

SieClear multi-view spatial compounding Note 3

8

S2000 Ultrasound System 510{k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

CW2 Probe for use with ACUSON S2000

NL Probe for use with ACUSON S2000
Ultrasound imaging or fluid flow analysis of the human body

Device Name: Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation Color Color Amplitude Combined Other B PWD CWD Clinical Application A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P Felal Abdominal P Intraoperative P (Note 9) Intraoperative Neurological Pediatric P Small Organ P {Note 1) P Neonatal Cephalic Adult Cephalic P Cardiac P Trans-esophageal Transrectal Transvaglnal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal P Superficial Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812

Additional Comments:

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Mary Slastel

Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and Safety

K111674
510K

9

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

CW5 Probe for use with ACUSON S2000

Device Name: Intended Use:

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

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

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K090334, , K093812

Additional Comments:

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

Note 9 For example: vascular, abdominal

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Mary Patel

Asion Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

S2000 510(k) Submission

Page 18 of 56

.

10

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

EC9-4 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11,14
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5, 6, 7,8,10,
11,14
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K092812

Additional Comments:

• Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
• Ensemble tissue harmonic imaging Nọte 2
• Note 3 SieClear multi-view spatial compounding
• Note 4 Tissue Equalization Technology
• Note 5 3-Scape real-time 3D imaging
• Cadence contrast agent imaging Note 6 B&W SieScape panoramic imaging
• Note 7
• Power SieScape panoramic imaging Note 8 Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Sieclear spatial compounding
• Note 14 eSie™ Touch elasticity imaging / FTI

Mary Stadel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

11

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known);

Device Name: Intended Use: 9L4 Linear Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
Small Organ
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11,14,
16
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
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 2,3,4,5,6, 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, 14,15
Musculo-skeletal
Superficial		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14,15
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K080334, K093812

Additional Comments:

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

• Ensemble tissue harmonic imaging Note 2
• Note 3 SieClear multi-view spatial compounding
• Tissue Equalization Technology Note 4
• Note 5 3-Scape real-time 3D imaging
• Note 6 Cadence contrast agent imaging
• Note 7 B&W SieScape panoramic imaging
• Note 8 Power SieScape panoramic imaging
• Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Sieclear spatial compounding
• Note 14 eSie™ Touch elasticity imaging / FTI
• Note 15 AHP
• Note 16 Custom Tissue Imaging

Mury Patel
(Division Sign-Off)

Division of Radiologic Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

12

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,6,
7,8,10, 11, 14
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11, 14
Musculo-skeletal
Superficial
Other (specify)

N = new indication: P = previously deared by FDA K# 063085, K072786, K081148, K082142, K093812

Additional Comments:

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

• Note 2 Ensemble tissue harmonic imaging
• SieClear multi-view spatial compounding Note 3
• Tissue Equalization Technology Note 4
• 3-Scape real-time 3D imaging Note 5
• Note 6 Cadence contrast agent imaging
• B&W SieScape panoramic imaging Note 7
• Power SieScape panoramic imaging Note 8
• Clarify VE vascular enhancement technology Note 10
• Advanced Sieclear spatial compounding Note 11
• Note 14 eSie™ Touch elasticity imaging / FTI
• Note 16 Custom Tissue Imaging

Mary S. Patel
(Division Sign-Off)

Divis on of Radiolonical Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

13

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

14L5BV Multi-D Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA K# 081148, K093812

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

• Tissue Equalization Technology Note 4
  Note 5 3-Scape real-time 3D imaging

• Note 6 Cadence contrast agent imaging

• Note 7 B&W SieScape panoramic imaging

• Note 8 Power SieScape panoramic imaging

• Note 10 Clarify VE vascular enhancement technology

• Note 11 Advanced Sieclear spatial compounding

• Note 14 eSie™ Touch elasticity imaging / FTI

• Note 16 Custom Tissue Imaging

Mary Slatl
(Division Sign-Off)

Division of Radiological Devic e Evaluation and Safety Office of In

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

14

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 4P1 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K083812

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Masy Sastl
(Division Sign-Off)

n of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K111674
510K

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

15

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

6C2 Curved Array Transducer for use with ACUSON S2000

Device Name: Intended Use:

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

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

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K09034, K093812

Additional Comments:

• Ensemble tissue harmonic imaging Note 2
  SieClear multi-view spatial compounding Note 3

• Tissue Equalization Technology Note 4

• 3-Scape real-time 3D imaging Note 5

• B&W SieScape panoramic imaging Note 7

• Power SieScape panoramic imaging Note 8

• Note 10 Clarify VE vascular enhancement technology

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

• Note 16 Custom Tissue Imaging

Mary Stath
(Division Sign-Off)

of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

16

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000 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
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P	P	P	P		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial

N = new indication; P = proviously deared by FDA K# 063085, K072786, K081148, K082812

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 Nole 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
• Note 11 Advanced Sieclear spatial compounding
• eSie™ Touch elasticity imaging / FTI Note 14
• Note 16 Custom Tissue Imaging

Mair Sostel
(Division Sign-Off)

of Radiological Device e Evaluation and Salety Office of In

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

. . .

17

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C1HD Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,
11
Abdominal		N	N	N	N	N	N		BMDC	Note2,3,4,5,6,7,8,
10, 11, 14, 16
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ		N	N	N	N	N	N		BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

3-Scape real-time 3D imaging Note 5

Cadence contrast agent imaging Note 6

• Note 7 B&W SleScape panoramic imaging
• Power SieScape panoramic imaging Note 8
• Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

• Note 14 eSie™ Touch elasticity imaging / FTI
• Note 16 Custom Tissue Imaging

Mary Patel
Division Sign-Off

OM on of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

18

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 4V1 Phased Array Transducer for use with ACUSON S2000 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
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K082142, K093812

Additional Comments:

• Note 2 Ensemble tissue harmonic imaging
  Note 3 SieClear multi view spatial compounding

• Note 4 Tissue Equalization Technology

• Note 5 3-Scape real-time 3D imaging

• Note 7 B&W SieScape panoramic imaging Power SieScape panoramic imaging Note 8

• Note 10 Clarify VE vascular enhancement technology

• Note 11 Advanced Sieclear spatial compounding

• Note 14 eSie™ Touch elasticity imaging / FTI

• Note 16 Custom Tissue Imaging

Mary Scott
(Division Sign-Off)

on of Radiolonical Devi Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

19

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 {k} Number (if known):

Device Name: Intended Use: · 10V4 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K083812

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

• Note 7 B&W SieScape panoramic imaging
  Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Mary Patel

---

(Division Sign Off)

of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K 1111674

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

20

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Indications For Use: 14L5 SP Linear Array Transducer for use with ACUSON S2000 Diagnostic imaging or fluid flow analysis of the human body as follows.

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 9)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Neurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11
Pediatric
Small Organ
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,6,
7,8,10, 11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial
Other (specify)

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

Additional Comments:

• Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
• Note 2 Ensemble tissue harmonic imaging
• Note 3 SieClear multi-view spatial compounding
• Tissue Equalization Technology Note 4
• Note 5 3-Scape real-time 3D imaging
• Note 6 Cadence contrast agent imaging
• B&W SieScape panoramic imaging Note 7
• Note 8 Power SieScape panoramic imaging
• For example: vascular, abdominal Note 9 Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI

Note 15 AHP Note 16 Custom Tissue Imaging

Mary Scottl

of Radiological Device Vitro Diagnostic Device Evaluation and Safety Office of In

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

21

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

7CF2 Curved array mechanical 3D transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,13
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatnic
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812

Additional Comments:

• Note 2 Ensemble tissue harmonic imaging
• SieClear multi-view spatial compounding Note 3
• Tissue Equalization Technology Note 4
• Note 5 3-Scape real-time 3D imaging
• B&W SieScape panoramic imaging Note 7
• Note 8 Power SieScape panoramic imaging
• Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Siectear spatial compounding
• Note 13 STIC

ו,

Mary Patel
(Division Sign-Off)

on of Radinlorical De Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

S2000 510(k) Submission

Page 30 of 56

22

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

バー - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

1

9EVF4 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,
10,11, 13
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,
10,11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,
10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K090334, K093812

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

Mary S. Patil
(Division Sign-Off)

ion of Radiological Devices Diagnostic Device Evaluation and Safety

510K Killy

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Image /page/22/Picture/22 description: The image shows a black and white drawing of an abstract shape. The shape is roughly square, but the lines are not straight and the corners are not sharp. The shape is also not solid, but rather made up of a series of lines and dots. The overall effect is one of incompleteness and ambiguity.

1 - - - -

23

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: V5Ms Multiplane TEE Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P	P		BMDC	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K082142, K093812

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

Additional Comments: Tissue Equalization Technology Note 4

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Part 21CFR 801 Subpart D)

Mary S Postel
(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K Y111674

S2000 510(k) Submission

Page 32 of 56

24

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

17L5HDS Linear Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA K# 063085, K072786, K082142, K090334 , K093812

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

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

Power SieScape panoramic imaging Note 8

• Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Sieclear spatial compounding
• Note 14 eSie™ Touch elasticity imaging / FTI

Mury Sastel
(Division Sign-Off)

of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

25

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

18L6 HD Linear Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		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, K082142, K090334, K093812

Additional Comments:

• Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
• Note 2 Ensemble tissue harmonic imaging
• SieClear multi-view spatial compounding Note 3
• Note 4 Tissue Equalization Technology
• 3-Scape real-time 3D imaging Note 5
• Note 7 B&W SieScape panoramic imaging
• Note 8 Power SieScape panoramic imaging
• Note 10 Clarify VE vascular enhancement technology
• Note 11 Advanced Sieclear spatial compounding
• Note 14 eSie™ Touch elasticity imaging / FTI

Note 15 AHP
Note 16 Custom Tissue Imaging

Muss S. Patel
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K 111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

26

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 8V3 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

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

Note 8

Note 10 Clarify VE vascular enhancement technology

Mary Scott

[Division Sign-Off]

of Radiological Devices Divis Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

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

27

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 4V1c Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Abdominal		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 052410, 051139, 041319, 032114, 022567, 063085, K090334, K093812

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

• Note 4 Tissue Equalization Technology
• Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

• B&W SieScape panoramic imaging Note 7
  Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

• Note 15 AHP
  Mass Slatel
  (Division Sign-Off)

Division of Radiological Devices ice Evaluation and Safety Vitro Diagnostic Dev Office of In

510K K111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

28

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6L3 Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11
Abdominal
Intraoperative
Abdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11
Intraoperative
Neurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11
Pediatric
Small Organ		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
1
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11 15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11
Musculo-skeletal
Superficial		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,
11

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, KD93812

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
• Note 11 Advanced Sieclear spatial compounding
• Note 15 AHP

Mary S. Pastel
(Division Sign-Off)

Division of Radiological Device Office of Ir Diagnostic Device Evaluation and Safety

510K K 111674

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

29

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: EV8C4 Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| 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 | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767, 063085, K090334, K093812

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

• B&W SieScape panoramic Imaging Note 7
  Note 8 Power SieScape panoramic Imaging Note 10 Clarify VE vascular enhancement technology

Mary S Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation

510K K111674

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

30

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

V7M TEE Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | Other
(Specify) |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P | Note 4 |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | Note 4 |
| Small Organ
(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | Note 4 |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P | Note 4 |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K032114, and #K022567, K093812

Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

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

Note 2 Ensemble tissue harmonic imaging

Tissue Equalization Technology Note 4

Note 10 Clarify VE vascular enhancement technology

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Sybpart D)

Mary S. Postel

Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111674

S2000 510(k) Submission

Page 39 of 56

31

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter for use with ACUSON S2000

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

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

P=Previously cleared by the FDA K992631, K033650, K042593, K071234, K093812

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Mary Slated
(Division Sign-Off)

of Radiological Devices Divisio Office of In Vitro Diagnostic Device Evaluation and Safety

S2000 510{k} Submission

Page 40 of 56

32

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter for use with ACUSON S2000

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-skeietal
Superficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P*

P=Previously cleared by the FDA K992631, K033650, K042593, K071234, , K093812

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

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

510K

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)

Mary Stotil
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

S2000 510(k) Submission

Page 41 of 56