SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER

K092922 · Sonoscape Company Limited · IYN · Mar 12, 2010 · Radiology

Device Facts

• Record ID: K092922
• Device Name: SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.

Device Story

The SonoScape S8 is a portable, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (phased, linear, micro-curved arrays) and displays images in B-Mode, M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 3D/4D. The system features a 64-channel digital beam former, progressive dynamic receive focusing, and wide-band digital demodulation. It is operated by qualified physicians in clinical settings. The system includes exam-dependent default settings and soft-menu controls for image optimization. Output is viewed on an integrated LCD monitor, aiding clinical diagnosis and patient management. Data can be transported via USB or managed remotely through a LAN port. The device benefits patients by providing non-invasive diagnostic imaging across multiple clinical applications.

Clinical Evidence

Bench testing only. The device underwent performance testing to verify imaging capabilities, safety, and compliance with ultrasound standards. No clinical data was required for this 510(k) submission.

Technological Characteristics

Portable diagnostic ultrasound system; 64-channel digital beam former; progressive dynamic receive focusing; wide-band digital demodulation; native frequency digital scan converter. Supports phased, linear, and curved array probes. Connectivity: LAN port, USB 2.0. Operating system: Linux. Imaging modes: B, M, TDI, Color/Power/Pulse Wave Doppler, 3D/4D. Sterilization: Transducers are reusable and require disinfection per labeling.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn, and Urology. For use by qualified physicians.

Regulatory Classification

Identification

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

Predicate Devices

• GE Voluson 730 Diagnostic Ultrasound System and Transducers (K003525)
• Shenzhen Mindray DC-7 Ultrasound (K092691)

Submission Summary (Full Text)

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KOS2992R

S8 Diagnostic Ultrasound System

### PREMARKET NOTIFICATION 510(K) SUMMARY

MAR 1 2 2010

Trade Name: SonoScape Ultrasound System, S8™

With: 2P1 Phase Array, 5P1 Phase Array, 6V1 Micro-curved Array, 6V3 Micro-curved Array, EC9-5 Micro-curved Array, C611 Micro-curved Array, C362 Curved Array, C344 Curved Array, VC6-2 Curved Arrày, L743 Linear Array, L741 Linear Array, L742 Linear Array.

Common Name: Diagnostic Ultrasound System

Classification Name: Ultrasonic Pulsed Echo Imaging System, 90 IYO

Manufacturer's Name: SonoScape Company Limited

4/F., Yizhe Building, Yuquan Road,

Nanshan, 518051, Shenzhen, China

Contact: Mr. Zhiqiang Chen, Vice-president Telephone: [phone] Fax: [phone]

U.S. Agent: Bob Leiker

Quality Regulatory Services, Inc.

Dublin, A 94568

### Predicate Devices:

GE Voluson 730 Diagnostic Ultrasound System and Transducers - K003525

Shenzhen Mindray DC-7 Ultrasound - K092691

Device Description: The SonoScape S8 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features,

Premarket Notification 510(k) Summary

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#### SonoScape Ultrasound

The SonoScape S8 System is configured as a portable model. The system is designed with the latest technology, using the same quality procedures as ultrasound systems, which have been available in the market for years.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The major features of the SonoScape S8:

- 64 Channel all digital beam former .
- Progressive dynamic receive focusing .
- Wide band all digital demodulation .
- Native frequency digital scan converter .
- . S8 can be hand carried for portable use
- Remote access image management through LAN port ●
- . USB2.0 flash drive for image transport and software upgrade
- Support for Phase array, Linear array, and Curve Linear array probes .
- Based on Linux operating system .
- Support 2D B-mode, M-mode, Harmonic Image, TDI, Color, Power . Doppler, Pulse wave Doppler, CW and 3D/4D.

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The S8 uses the LCD viewing monitor. The following drawings are provided for illustration;

Image /page/2/Figure/3 description: The image shows three different views of an electronic device, possibly a monitor or a specialized computer. The views include the front, side, and back of the device, providing a comprehensive look at its design and features. The back view reveals various ports and ventilation areas, suggesting its functionality and connectivity options. The text "S8" is present at the bottom of the image, potentially indicating a model number or series.

- Intend Use: The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.
Premarket Notification 510(k) Summary

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

SonoScape Company Limited % Mr. Bob Leiker Quality & Regulatory Services Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568

MAR 1 2 2010

Re: K092922

Trade/Device Name: SonoScape S8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 4, 2010 Received: March 8, 2010

Dear Mr. Leiker:

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 SonoScape S8 Diagnostic Ultrasound System, as described in your premarket notification:

### Transducer Model Number

2P1 Phased Array 5P1 Phased Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array

C362 Curved Array C344 Curved Array VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array

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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 your

Dudley Rob

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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SonoScape Ultrasound

# Tab 3 Indications for Use

510(k) Number (if known): K092922

Device Name: SonoScape S8 Diagnostic Ultrasound System

Indications For Use: The SonoScape S8 device is a general-purpose ultrasonic imaging . instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter<br>(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)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K092922 |
|------|---------|
|------|---------|

Tab 3 Indications For Use Page 1 of 14

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#### Sonoscape S8 System: Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | Other* | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|-------------------------------------------------------------------|------------------|---------------------------------|-----------------------------------------------------------------|---------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2, 4, 5 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2,4,6 |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,4 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,4 |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2, 4, 5 |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>Vessel | Other (specify)<br>Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2 |
| | Other (specify) | | | | | | | | |
| N = new indication; | Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power<br>Doppler/PWD | | | | | | | P = previously cleared by FDA;<br>E = added under this appendix | |
| | Note 2: Tissue Harmonic Imaging | | Note 3: TDI | | Note 4: 3D | | Note 5: 4D | | |
| | Note 6: Small Organ: breast, thyroid, testes | | | | | | | | |
| Prescription Use ✓<br>(Part 21 CFR 801 Subpart D) | | | | | AND/OR | | | Over-The-Counter<br>(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) | | | | |
| Image: Signature | | | | | | | | | |
| (Division Sign-Off) | | | | | | | | | |
| Division of Radiological Devices<br>Office of In Vitro Diagnostic Device Evaluation and Safety | | | | | | | | | |
| 510K. K092922 | | | | | | | | | |
| Tab 3<br>Indications For Use<br>Page 2 of 14 | | | | | | | | | |

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#### 2P1 Phase Array Transducer: Diagnostic Ultrasound Transducer

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

| Clinical Application | | | Mode of Operation | | | | | | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---|-------------------|--------------------------------|--------|-------------------------------------------------------------------|-------------|-------------------------------|-----------|--|--|
| General | Specific | | | | | Color | Power | Other* | Other* | | |
| (TRACK 1 | (TRACKS 1 & 3) | | B M | PWD | CWD | Doppler | (Amplitude) | Combined | Specify | | |
| ONLY) | | | | | | | Doppler | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal | Fetal | | | | | | | | | | |
| Imaging& | | | | | | | | | | | |
| Other | Abdominal | N | N | N | | N | N | Note 1 | Notes 2 | | |
| | Intra-operative Specify | | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | 1 | | |
| | Small Organ (specify) | | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | | |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | | |
| | (Conventional) | | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | | |
| | (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | ನ | N | N | Note 1 | Notes 2,3 | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 | | |
| | Intravascular(Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (specify) | | | | | | | | | | |
| N = new indication; | | | | P = previously cleared by FDA; | | | | E = added under this appendix | | | |
| | Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler;PWD; B/Power | | | | | | | | | | |
| | Doppler/PWD | | | | | | | | | | |
| | Note 2: Tissue Harmonic Imaging | | | Note 3: TDI | | Note 4: 3D | | Note 5: 4D | | | |
| | Note 6: Small Organ: breast, thyroid, testes | | | | | | | | | | |
| | | | | | | | | | | | |
| Prescription Use | V | | | | AND/OR | | | Over-The-Counter | | | |
| (Part 21 CFR 801 Subpart D) | | | | | | | | (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 (OFVD) | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| Division Sign-Off<br>Division of Radiological Devices | | | | | | | | | | | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |

Indications For Use

,

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Page 3 of 14

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# Diagnostic Ultrasound Indications for Use Form

#### Transducer: 5P1 Phase Array Diagnostic Ultrasound Transducer

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

| Clinical Application | Mode of Operation | | | | | | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---|---|-------------|--------|------------|------------|-------------------------------|-----------|
| General | Specific | | | | | Color | Power | Other* | Other* |
| (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | Amplitude) | Combined | Specify |
| ONLY) | | | | | | | Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | | | | | | | | |
| Imaging& | | | | | | | | | |
| Other | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | (Conventional) | | | | | | | | |
| | Musculo-skeletal | | | | | | | | |
| | (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (specify) | | | | | | | | |
| N = new indication; | P = previously cleared by FDA; | | | | | | | E = added under this appendix | |
| | Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power | | | | | | | | |
| | Doppler/PWD | | | | | | | | |
| | Note 2: Tissue Harmonic Imaging | | | Note 3: TDI | | Note 4: 3D | | Note 5: 4D | |
| | Note 6: Small Organ: breast, thyroid, testes | | | | | | | | |
| | | | | | | | | | |
| Prescription Use | V | | | | AND/OR | | | Over-The-Counter | |
| | (Part 21 CFR 801 Subpart D) | | | | | | | (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) | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| (Division Sign-Off) | | | | | | | | | |
| Division of Radiological Devices | | | | | | | | | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |

Indications For Use

.

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í

### Diagnostic Ultrasound Indications for Use Form

#### Transducer: 6V1 Micro-curved Array Diagnostic Ultrasound Transducer

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

| Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------|---|-------------|--------|------------------|---------------------------------|--------------------------------------------|-------------------|
| General<br>(TRACK 1 ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N = new indication; | P = previously cleared by FDA; E = added under this appendix | | | | | | | | |
| Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | | | | | | | | | |
| | Note 2: Tissue Harmonic Imaging | | | Note 3: TDI | | Note 4: 3D | | Note 5: 4D | |
| | Note 6: Small Organ: breast, thyroid, testes | | | | | | | | |
| Prescription Use _ V<br>(Part 21 CFR 801 Subpart D) | | | | | AND/OR | | | Over-The-Counter<br>(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) | | | | | | | | | |
| | | | | | | | | | |
| <div align="center">(Division Sign-Off<br/>Division of Radiological Devices<br/>Office of In Vitro Diagnostic Device Evaluation and Safety</div> | | | | | | | | | |
| | | | | | | | | | |
| 510K K092922 | | | | | | | | | |

Indications For Use

Tab 3

·

Page 5 of 14

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#### Transducer: 6V3 Micro-curved Array Diagnostic Ultrasound Transducer

lntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…