PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

K131088 · Sonoscape Company Limited · IYN · May 24, 2013 · Radiology

Device Facts

• Record ID: K131088
• Device Name: PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: May 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonoScape S9 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Story

S9 Portable Digital Color Doppler Ultrasound System is a general-purpose, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (curved, micro-curved, linear, and phased arrays) and displays images in B-Mode, M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 3D/4D modes. The system features an all-digital architecture with progressive dynamic receive focusing to enhance image detail and diagnostic confidence. It is intended for use by qualified physicians in clinical settings. Users interact with the system via an exam-dependent default setting or an in-depth soft-menu control for advanced adjustments. The device provides real-time diagnostic imaging to assist in clinical evaluation and decision-making across multiple medical specialties. It supports cost-effective integration of upgradeable features.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through acoustic output measurements, electrical safety, electromagnetic compatibility, and biocompatibility testing in accordance with FDA-recognized standards.

Technological Characteristics

Portable digital color Doppler ultrasound system. Transducers: curved, micro-curved, linear, and phased arrays (1.0-12.0 MHz). Architecture: all-digital with progressive dynamic receive focusing. Modes: B, M, PWD, CWD, Color Doppler, Power Doppler, 3D/4D, Tissue Harmonic Imaging (THI), TDI. Connectivity: software-controlled. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10. Acoustic output: NEMA UD 2, NEMA UD 3.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urology applications. Contraindications: none stated.

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

• SonoScape S6 (K112602)

Submission Summary (Full Text)

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K13/088
510(k) Submission Page 1 of 5

# 510(k) Summary

# MAY 2 4 2013

[As required by 21 CFR 807 92]

# 1. Date Prepared [21 CFR807.92 (a) (1)]

March 30, 2012

# 2. Submitter's Information [21 CFR807.92 (a) (1)]

| Name of Sponsor: | SonoScape Company Limited |
|------------------|---------------------------------------------------------------------|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen<br>518051, P.R.China |
| Contact Name: | Zhou Wenping |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |
| Email Address: | [e-mail] / [e-mail] |

# 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

| Trade Name: | S9 Portable Digital Color Doppler Ultrasound System | | |
|---------------------------------------------------------|-----------------------------------------------------|-------------------|--|
| Common Name: | Diagnostic Ultrasound System and Transducers | | |
| Classification: | | | |
| 21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System | | Product code: IYN | |
| 21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System | | Product code: IYO | |
| 21 CFR892.1570 Diagnostic Ultrasonic Transducer | | Product code: ITX | |
| Classification Panel: | Radiology | | |
| Device Class: | II | | |

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicates within this submission are as follows:

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SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date – November 07, 2011).

# 5. Description of the Device [21 CFR 807.92(a)(4)]

The SonoScape S9 Portable Digital Color Doppler 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.

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.

# 6. Intended Use [21 CFR 807.92(a)(5)]

The SonoScape S9 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

## 7. Technological Characteristics [21 CFR 807.92(a)(6)]

| No. | Probe | Type | Frequency<br>Range | Intended Use |
|-----|-------|-----------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 1 | C344 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 2 | C353 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| No. | Probe | Type | Frequency<br>Range | Intended Use |
| 3 | C322 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 4 | VC6-2 | curved Array | 2.0-6.0 MHz | Fetal/ Abdominal/ Ob/GYN |
| 5 | 6V1 | Micro-curved<br>Array | 4.0-8.0 MHz | Trans-rectal<br>Trans-vaginal |
| 6 | 6V3 | Micro-curved<br>Array | 5.0-9.0 MHz | Trans-rectal<br>Trans-vaginal |
| 7 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid, testes)<br>Musculo-skeletal (Conventional)<br>Peripheral vessel |
| 8 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid, testes)<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
| 9 | L752 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid, testes)<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
| 10 | 2P2 | Phase Array | 1.0-5.0 MHz | Abdominal<br>Cephalic(neonatal and adult)<br>Cardiac (neonatal and adult) |
| 11 | 3P1 | Phase Array | 1.0-5.0 MHz | Abdominal<br>Cephalic(neonatal and adult)<br>Cardiac (neonatal and adult) |
| 12 | 5P2 | Phase Array | 3.0-8.0 MHz | Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |
| 13 | 8P1 | Phase Array | 4.0-12.0 MHz | Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |

#### Table 1 Transducer Information

510(k) Summary

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510(k) Submission

# 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

Safety Considerations:

510(k) Summary

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The S9 Portable Digital Color Doppler Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-5and ISO 10993-10.

#### Testing:

Laboratory testing was conducted to verify that the S9 Portable Digital Color Doppler Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

| Standards<br>No. | Standards Title | Version | Date |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| IEC 60601-1 | Medical Electrical Equipment - Part1.<br>General Requirements for Safety | 1988+A1:<br>1991+A2:<br>1995 | 10/31/2005 |
| IEC<br>60601-1-2 | Medical Electrical Equipment, Part 1-2:<br>General Requirements for Safety –<br>Collateral Standard: Electromagnetic<br>Compatibility – Requirements and Tests | 2007 | 03/01/2007 |
| IEC<br>60601-2-37 | Medical Electrical Equipment, Part 2-37:<br>Particular Requirements for the Safety of<br>Ultrasonic Medical Diagnostic and<br>Monitoring Equipment | 2007 | 08/01/2007 |

#### Tab 2 Applicable Safety Standards

510(k) Summary i

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K/3/088

Portable Digital Color Doppler Ultrasound System

510(k) Submission

| NEMA UD 2 | Acoustic Output Measurement Standard for<br>Diagnostic Ultrasound Equipment Version 3 | 2004 | 01/01/2004<br>(R 2009) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|------|------------------------|
| NEMA UD3 | Standard for Real-Time Display of Thermal<br>and Mechanical Acoustic Output Indices on<br>Diagnostic Ultrasound Equipment | 2004 | 01/01/2004<br>(R 2009) |
| ISO 10993-5 | Biological evaluation of medical devices -<br>Part 5: Tests for In Vitro cytotoxicity | 1999 | 05/15/1999 |
| ISO<br>10993-10 | Biological evaluation of medical devices -<br>Part 10: Tests for irritation and delayed-type<br>hypersensitivity | 2002 | 09/01/2002 |

Results of performance and compliance testing conducted on the S9 Portable Digital Color Doppler Ultrasound System, indicates conformance to all applicable standards recognized by FDA for this device.

Based on non-clinical test results, S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.

# 9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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Image /page/5/Picture/0 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-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### May 24, 2013

SonoScape Company Limited % Ms. Toki Wu Yizhe Building, Yuquan Road, NanShan Shenzhen, Guangdong 518051 P.R. CHINA

Re: K131088

Trade/Device Name: S9 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: March 26, 2013 Received: April 18, 2013

Dear Ms. Wu:

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 S9 Portable Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P2 Phase Array 8P1 Phase Array C344 Curved Array VC6-2 Curved Array 3P1 Phase Array 6V1 Micro-curved Array C353 Curved Array L741 Linear Array L752 Linear Array

5P2 Phase Array 6V3 Micro-curved Array C322 Curved Array L742 Linear Array

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Page 2 - Ms. Toki Wu

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/RcportaProblem/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, Ph.D. at [phone].

Sincerely yours,

Smh.7)

for

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

Enclosures

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Portable Digital Color Doppler Ultrasound System

510(k) Submission

# Indications for Use

K131088 510(k) Number (if known):

Device Name:

S9 Portable Digital Color Doppler Ultrasound System

Indications for Use:

The SonoScape S9 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR:807 Subpart C)

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

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

(m-7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) = K131088

Indications for Use

Page 1 of 15

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System:

SonoScape S9

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 | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>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 | 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 2,3,4 |
| Fetal | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Imaging&<br>Other | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | 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 Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2,4 |
| Vessel | Other (specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

- Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

Indications for Use

Page 2 of 15

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### Transducer: 2P2 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CW<br>D | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | 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. The feature does not use contrast agents

Note 3: TDI Note 5: 4D

- Note 6: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

Indications for Use

Page 3 of 15

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## Transducer: 3P1 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<br>ONLY) | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude<br>) Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal | Fetal | | | | | | | | | |
| Imaging& | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 | |
| Other | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1. | Notes 2,3,4 | |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| | 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 | N | N | N | Note 1 | Notes 2,3,4 | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| | 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 M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI . Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

Indications for Use

Page 4 of 15

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## Transducer: 5P2 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<br>(TRACK 1<br>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 | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | 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. The feature does not use contrast agents

Note 3: TD! Note 4: 3D . · Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) __

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

### Transducer: 8P1 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<br>ONLY) | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude<br>) Doppler | Combined | Specify | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 | | |
| | Small Organ (specify) | | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph(non-Card) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | |
| | Intravascular(Cardiac) | | | | | | | | | | |
| | Trans-esoph (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | 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 Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) .

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

## 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 | | | | | | 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 | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | 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. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

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

Transducer: 6V3 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<br>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 | P | P | P | | P | P | Note 1 | Notes 2,4 | | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2,4 | | |
| | 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. The feature does not use contrast agents

Note 3: TDI . Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

{15}------------------------------------------------

### Transducer: C344 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<br>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 | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Abdominal | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other. (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| 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. The feature does not use contrast agents

- Note 3: TDI Note 4: 3D Note 5: 4D .
Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

{16}------------------------------------------------

### Transducer: C353 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<br>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 | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |

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 Doppier/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

- Note 6: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

Indications for Use

Page 10 of 15

{17}------------------------------------------------

## Transducer: C322 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<br>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 | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1' | Notes 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify)…