CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE

K131305 · Chison Medical Imaging Co., Ltd. · IYN · Aug 1, 2013 · Radiology

Device Facts

• Record ID: K131305
• Device Name: CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
• Applicant: Chison Medical Imaging Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 1, 2013
• 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 Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

Device Story

Compact, portable diagnostic ultrasound system (models ECO1-ECO6) featuring integrated keyboard, LED display, and interchangeable electronic-array transducers. System transmits ultrasonic energy into patients; receives echoes; performs digital acquisition and post-processing to generate real-time on-screen display of anatomic structures and fluid flow. Operated by qualified physicians in clinical settings. Provides specialized measurements and calculations for clinical assessment. Benefits include non-invasive visualization of internal structures and hemodynamics to aid diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through compliance with recognized electrical and physical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3) and comparison of acoustic output levels to FDA limits.

Technological Characteristics

Portable ultrasound system with LED display and electronic-array transducers. Modes: B, M, PWD, Color Doppler, Power Doppler, THI, and combined modes. Connectivity: Digital acquisition/processing. Safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1.

Indications for Use

Indicated for qualified physicians to perform diagnostic ultrasound imaging and fluid flow analysis in fetal/OB, abdominal (GYN/urology), pediatric, small organ (breast, testes, thyroid), cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), transrectal, and transvaginal applications.

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 LOGIQ e Ultrasound System (K102256)

Reference Devices

• GE LOGIQ i (K102256)
• Vivid e Diagnostic Ultrasound (K102256)

Submission Summary (Full Text)

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#### AUG 1 2013

# PREMARKET NOTIFICATION [510(k)] Summary

This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).

# 1. Company Name:

Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142 Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142

- Ms. Ruoli Mo Contact: Tel: [phone] Fax: [phone]
- U.S. Agent: Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568
- Contact: Bob Leiker Tel: [phone] Fax: [phone]
- 2. Device Name: ECO Series Diagnostic Ultrasound System

Common/Usual Name: Diagnostic Ultrasound System with Accessories

Classification: Requlatory Class: II Review Category: Tier II

| Classfication Name | 21 CFR Section | Product Code |
|------------------------------------------|----------------|--------------|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |

# 2. Marketed Device:

K102256,GE LOGIQ e Ultrasound System

# 3. Device Description:

The ECO Series Diagnostic Ultrasound Systems is a very compact and portable diagnostic ultrasound system having five variations: ECO6, ECO5, ECO3, ECO2, and ECO1, each with options and features suited for its market niche. It has an integrated keyboard, LED display and several interchangeable electronic-array transducers and provides digital acquisition, processing and display capability. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display.

The ECO Series Models, have been designed to meet the following product safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.

{1}------------------------------------------------

### 4. Indications for Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

# Comparison to Predicate Device:

The ECO Series Models is of comparable type and substantially equivalent to the GE LOGIQ i, LOGIQ e, and the Vivid e Diagnostic Ultrasound (K102256). All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations.

### 5. Conclusion:

The ECO Series Models is substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. . The systems have the same gray-scale. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.

End of 510(k) Summary.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines representing the snakes, and the text is in all capital letters.

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

August 1, 2013

Chison Medical Imaging Co., Ltd. % Mr. Bob Leiker Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568

Re: K131305

Trade/Device Name: ECO Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 29. 2013 Received: June 28, 2013

Dear Mr. Leiker:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Transducer Model Number

| C3-A<br>MC3-A<br>V6-A | L7M-A<br>L7S-A<br>R7-A | P3-A<br>MC6-A |
|-----------------------|------------------------|---------------|
|-----------------------|------------------------|---------------|

{3}------------------------------------------------

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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

Enclosure

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# Diagnostic Ultrasound Indications For Use

# 1.3 Indications for Use

510(K) Number: K131305

Device Name: ECO Series Diagnostic Ultrasound Systems

Indications for use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

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)

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

510(k)

Section 1.3

{5}------------------------------------------------

# Diagnostic Ultrasound Indications For Use

ECO Series Diagnostic Ultrasound Systems 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 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 |
| | Abdominal | N | N | N | | N | N | Note 1 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 |
| | Small Organ(1) (Specify) | N | N | N | | N | N | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | Note 1 |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI,B+Color Doppler+PWD. B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) 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)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) ======================================================================================================================================================================= K131305

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#### System: ECO Series Diagnostic Ultrasound Systems Transducer: C3-A, Convex Array

| 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 |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | N | N | N | | N | N | Note 1 |
| | Abdominal | | N | N | N | | N | N | Note 1 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | N | N | N | | N | N | Note 1 |
| | Small Organ[1] (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | N | N | N | | N | N | Note 1 |
| | Other (Ob/GYN) | | N | N | N | | N | N | Note 1 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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

P = previously cleared by FDA; N = new indication; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI.B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

| Prescription Use | X |
|-----------------------------|---|
| (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)

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

#### ECO Series Diagnostic Ultrasound Systems System: Transducer: MC3-A, Micro-convex Array

| 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 | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging & | Fetal | | | | | | | | |
| Other | Abdominal | N | N | N | | N | N | Note 1 | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ(1) (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 | |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THLB+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) 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)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________

{8}------------------------------------------------

#### ECO Series Diagnostic Ultrasound Systems System:

Transducer: V6-A, Micro-convex Array

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|
| General<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | Note 1 |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M. B+PWD, B+Color Doppler, B+Power Doppler, B+THI,B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid. testes and breast

Prescription Use _ x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21CFR 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)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K131305

{9}------------------------------------------------

Transducer: L7M-A, Linear Array

| | Clinical Application | | | | | Mode of Operation | | |
|-------------------|---------------------------------|---|---|-----|-----|-------------------|------------------------|----------|
| | | | | | | | | |
| General | Specific | B | M | PWD | CWD | Color | Power | Other* |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | Doppler | (Amplitude)<br>Doppler | Combined |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging & | Fetal | | | | | | | |
| Other | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 |
| | Small Organ[1] (Specify) | N | N | N | | N | N | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 |
| | Other (Specify) | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI,B+Color Doppler+PWD. B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

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

Transducer: L7S-A, Linear Array

| | 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 |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 |
| | Small Organ[1] (Specify) | N | N | N | | N | N | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 |
| | Other (Specify) | | | | | | | |

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

P = previously cleared by FDA; N = new indication; E = added under this appendix Note I: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI.B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

x Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

{11}------------------------------------------------

Transducer: R7-A, Linear Array

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 | Power | Other* | | |
| (Track I Only) | (Tracks 1 & 3) | | | | | Doppler | (Amplitude)<br>Doppler | Combined | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging & | Fetal | | | | | | | | | |
| Other | 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 | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | Note 1 | | |
| | Other (Ob/GYN) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral Vessel Peripheral vessel | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E == added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI,B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) 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)

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Transducer: P3-A, Phased Array

| | 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 |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ[1] (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Urology) | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+THI,B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

× Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) 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)

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

#### System: ECO Series Diagnostic Ultrasound Systems Transducer: MC6-A, Convex Array

| 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 | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | |
| | Small Organ(1) (Specify) | N | N | N | | N | N | Note 1 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

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

Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+TH1,B+Color Doppler+PWD, B+Power Doppler+PWD

Comments: Small Organ: Thyroid, testes and breast

| Prescription Use | x |
|-----------------------------|---|
| (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) Sinh -