C5 Diagnostic Ultrasound System

K171926 · Guangzhou Sonostar Technologies Co., Ltd. · IYN · Oct 27, 2017 · Radiology

Device Facts

• Record ID: K171926
• Device Name: C5 Diagnostic Ultrasound System
• Applicant: Guangzhou Sonostar Technologies Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

C5 Diagnostic Ultrasound System 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), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Story

C5 Diagnostic Ultrasound System is a mobile, software-controlled, color diagnostic ultrasound system. It transmits ultrasonic energy into the patient body and processes received echoes to generate real-time displays of anatomic structures and fluid flow. The system includes a mobile console, keyboard control panel, power supply, color LCD monitor, and various probes (linear, convex, trans-vaginal, micro-convex). It is operated by qualified physicians in clinical settings. The device supports B-Mode, M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, and Power Doppler, as well as combined modes. Output is displayed on the integrated monitor for clinical evaluation of anatomy and blood flow. The system aids physicians in diagnostic decision-making by providing high-resolution imaging and measurement capabilities for various clinical applications.

Clinical Evidence

No clinical data was performed or submitted. Safety and effectiveness were established through non-clinical bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance safety (IEC 60601-2-37).

Technological Characteristics

Mobile console with 15-inch LCD monitor; embedded Linux OS; supports linear, convex, trans-vaginal, and micro-convex probes. Processing includes autocorrelation for color and FFT for pulse Doppler. Connectivity via USB for software updates. Evaluated per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for use by qualified physicians for diagnostic ultrasound imaging and fluid flow analysis of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), trans-vaginal, peripheral vascular, musculo-skeletal (conventional and superficial), cardiac (neonatal and adult), OB/Gyn, and urological structures.

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

• S12 Digital Color Doppler Ultrasound System (K142474)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Guangzhou Sonostar Technologies Co., Ltd. % Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang 325000 CHINA

Re: K171926

Trade/Device Name: C5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 1, 2017 Received: August 14, 2017

Dear Ms. Nan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 27, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

**Robert Oaks**

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K171926

Device Name C5 Diagnostic Ultrasound System

#### Indications for Use (Describe)

C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape cut out of the top left corner. To the right of the star is the text "SonoStar" in a bold, green font.

| System: | C5 Diagnostic Ultrasound System | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------------------------|-----------------|
| 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>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | | | | N | N - Note 1<br>N - Note 2<br>N - Note 3 | N |
| | Abdominal | N | | | | N | N - Note 3 | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | N | N - Note 1 | N |
| | Small Organ<br>(breast, testes, thyroid) | N | | | | N | N - Note 1 | N |
| Fetal<br>Imaging<br>&Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | | | | N | N - Note 1 | N |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | | | | | | N |
| | Musculo-skeletal<br>(Superficial) | N | | | | | | N |
| | Intravascular | | | | | | | |
| | Other (OB/Gyn) | N | N | N | | N | N - Note 1<br>N - Note 2<br>N - Note 3 | N |
| | Other (Urology) | N | | | | N | N - Note 1 | N |
| | Cardiac Adult | N | N | N | | N | N - Note 3<br>N - Note 1<br>N - Note 2 | N |
| Cardiac | Cardiac Pediatric | N | N | N | | N | N - Note 3<br>N - Note 1<br>N - Note 2 | N |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | | N | | N | N - Note 1<br>N - Note 2 | N |
| | Other (Specify) | | | | | | | |
| System: | C5 Diagnostic Ultrasound System | | | | | | | |
| Transducer: | Convex Array Transducer (3C6C) | | | | | | | |
| 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>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>&Other | Fetal | N | N | N | | N | N - Note 1 | N |
| | | | | | | | N - Note 2 | |
| | | | | | | | N - Note 3 | |
| | Abdominal | N | | | | N | N - Note 1 | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(breast, testes, thyroid) | | | | | | | |
| | 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 | N |
| | | | | | | | N - Note 2 | |
| | | | | | | | N - Note 3 | |
| | Other (Urology) | N | | | | N | N - Note 1 | N |
| Cardiac | Cardiac Adult | N | N | N | | N | N - Note 3 | N |
| | | | | | | | | N - Note 1 |
| | | | | | | | | N - Note 2 |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/4/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.

#### Diagnostic Ultrasound Indications For Use Format

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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/5/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape in the upper left corner. To the right of the star is the word "SonoStar" in a stylized, green font.

| System: | C5 Diagnostic Ultrasound System | | | | | | | | |
|----------------------------|--------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|-----------------|--|
| Transducer: | Linear Array Transducer (7L4C) | | | | | | | | |
| | Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) | |
| (Track 1 Only) | (Track 1&3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | | | | N | N - Note 1 | N | |
| | Small Organ | N | | | | N | N - Note 1 | N | |
| | (breast, testes, thyroid) | | | | | | | | |
| Fetal<br>Imaging<br>&Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | N | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/Gyn) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | | | | N | N - Note 1 | N | |
| | Other (Specify) | | | | | | | | |

#### Diagnostic Ultrasound Indications For Use Format

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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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

Image /page/6/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.

| Diagnostic Ultrasound Indications For Use Format | | | | | | | | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-------------------|-----|------------------|----------------------------------------|-----------------|
| System: | C5 Diagnostic Ultrasound System | | | | | | | |
| Transducer: | Trans-vaginal Transducer (6E1C) | | | | | | | |
| | 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>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N - Note 3 | N |
| | | | | | | | N - Note 1 | |
| | | | | | | | N - Note 2 | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(breast, testes, thyroid) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal<br>Imaging<br>&Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | N | | | | N | N - Note 1 | N |
| | 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 | N |
| | | | | | | | N - Note 2 | |
| | | | | | | | N - Note 3 | |
| | Other (Urology) | N | | | | N | N - Note 1 | N |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| System: | C5 Diagnostic Ultrasound System | | | | | | | |
| Transducer: | Micro-Convex Array Transducer (6C15C) | | | | | | | |
| | 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>(Track 1&3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(PDI) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | N | N - Note 1 | N |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | N | | N | N - Note 1<br>N - Note 2 | N |
| | Small Organ<br>(breast, testes, thyroid) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal<br>Imaging<br>&Other | 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<br>N - Note 2<br>N - Note 3 | N |
| | Other (Urology) | N | | | | N | N - Note 1 | N |
| | Cardiac Adult | N | N | N | | N | N - Note 3<br>N - Note 1<br>N - Note 2 | N |
| Cardiac | Cardiac Pediatric | N | N | N | | N | N - Note 3<br>N - Note 1<br>N - Note 2 | N |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-epoph. (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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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

#### Diagnostic Ultrasound Indications For Use Format

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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/8/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font. The text is slightly bolded and the letters are evenly spaced.

#### 007 510(k) Summary

(As required by 21 CFR 807.92(a))

#### 7.1 Submitter Information

- · Company: Guangzhou Sonostar Technologies Co., Ltd.
- · Address: 504#, C Building, #27 Yayingshi Road, Science Town,

Guangzhou, Guangdong, 510665, P.R.China

- ・ Phone: [phone]
- ・ Fax: [phone]
- · Contact: Weizhong Cai, General Manager
- · Date: May 01, 2017

#### 7.2 Device Information

- · Trade/Device Name: Diagnostic Ultrasound System
- Model: C5
- · Common Name: Diagnostic Ultrasound System and Transducer
- · Classification: 1) Device: System, Imaging, Pulsed Doppler, Ultrasonic

Regulation Description: Ultrasonic pulsed doppler

imaging system

Review Panel: Radiology

Product Code: IYN

Submission Type: 510(k)

Regulation Number: 21 CFR 892.1550

Device Class: 2

- 2) Device: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Description: Ultrasonic pulsed echo imaging

system

Review Panel: Radiology

Product Code: IYO

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Regulation Number: 21 CFR 892.1560 Device Class: 2 3) Device: Transducer, Ultrasonic, Diagnostic Regulation Description: Diagnostic ultrasonic transducer Review Panel: Radiology Product Code: ITX Regulation Number: 21 CFR 892.1570 Device Class: 2

## 7.3 Predicate Device Information

S12 Digital Color Doppler Ultrasound System submitted by SonoScape Company Limited 510K Number: K142474

## 7.4 Device Description

The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

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

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").

## 7.5 Indications for Use

C5 Diagnostic Ultrasound System 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), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

# 7.6 Comparison of Technological Characteristics with the Predicate Device

| | 7.6.1 Comparison Table of Technological Characteristic with the | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | | |
| Comparison Items | Subject Device:<br>Diagnostic Ultrasound<br>System<br>(Model: C5) | Predicate Device:<br>S12 Digital Color<br>Doppler Ultrasound<br>System<br>(K142474) |
| Classification & Intended Use | | |
| Classification | Product Codes:<br>IYN & IYO & ITX<br>Class: 2 | Product Codes:<br>IYN & IYO & ITX<br>Class: 2 |
| Intended Use | A general-purpose<br>ultrasonic imaging | A general-purpose<br>ultrasonic imaging |
| | | |
| | instrument intended for<br>use by a qualified<br>physician for<br>evaluation of Fetal,<br>Abdominal, Pediatric,<br>Small Organ (breast,<br>testes, thyroid),<br>Trans-vaginal,<br>Peripheral Vascular,<br>Musculo-skeletal<br>(Conventional and<br>Superficial), Cardiac<br>(neonatal and adult),<br>OB/Gyn and Urology. | instrument intended for<br>use by a qualified<br>physician for<br>evaluation of Fetal,<br>Abdominal, Pediatric,<br>Small Organ (breast,<br>testes, thyroid),<br>Cephalic(neonatal and<br>adult), Trans-rectal,<br>Trans-vaginal,<br>Peripheral Vascular,<br>Musculo-skeletal<br>(Conventional and<br>Superficial), Cardiac<br>(neonatal and adult),<br>OB/Gyn and Urology. |
| Technological Characteristics | Based on an embedded<br>Linux Operating<br>System | Based on an embedded<br>Linux Operating<br>System |
| | Autocorrelation for<br>color processing and<br>FFT for pulse. | Autocorrelation for<br>color processing and<br>FFT for pulse and CW<br>Doppler processing. |
| Design | Supporting Linear<br>probes (7.5MHz & 6.5<br>MHz) and Convex<br>array probes (3.5MHz | Supporting Linear,<br>Curve linear and Phase<br>array probes from 2 to<br>15MHz |
| | Cine play back | Cine play back |
| | capability | capability |
| | Image file archive | Image file archive |
| | Software upgrade with | Software upgrade with |
| | USB flash drive | USB flash drive |
| | | Digital Scan Converter |
| | 1024×768 | 800×600 |
| | With full keyboard | With full keyboard |
| | panel | panel |
| | TGC 8 slider | TGC 8 slider |
| | Depth Range: 3.6 to | Depth Range: 3 to |
| | 35.1cm | 24.8cm |
| | B Dynamic range | B Dynamic range |
| | control: 30-165dB | control: 20-280dB…