CHISON DIAGNOSTIC ULTRASOUND SYSTEM

K120801 · Chison Medical Imaging Co., Ltd. · IYN · Jun 14, 2012 · Radiology

Device Facts

• Record ID: K120801
• Device Name: CHISON DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Chison Medical Imaging Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jun 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for the evaluation of Fetal (Obstetrics), Abdomen, Cardiac (Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.

Device Story

Integrated preprogrammed color Doppler ultrasound system; available as portable (Q6/Q8) or roll-around (iVis60/iVis60 EXPERT/i7) models. Acquires ultrasound echo data to display images in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Power Doppler, and Directional Power Doppler modes. Used by physicians in clinical settings for diagnostic imaging and fluid flow analysis. System processes received echoes to generate on-screen displays of anatomic structures and fluid flow; supports specialized measurements and calculations. Benefits include non-invasive visualization of internal structures and hemodynamics to aid clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by compliance with NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1 standards.

Technological Characteristics

Diagnostic ultrasound system; portable or roll-around form factors. Modes: B, M, PW, CW, Color, Power, Directional Power Doppler, Tissue Harmonic Imaging. Transducers: Convex, Micro-convex, Linear, Phased arrays. Connectivity: Standard ultrasound interface. Software-controlled. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for qualified physicians to perform diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, cardiac (adult/pediatric), small organ (thyroid, testes, breast), peripheral vascular, transvaginal, musculoskeletal (conventional/superficial), pediatric, OB/Gyn, and urological 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 Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System (K101236)

Submission Summary (Full Text)

{0}------------------------------------------------

K120801

JUN 1 4 2012

Chison Medical Imaging Co., Ltd

iVis & Q Series, i7 Diagnostic Ultrasound Systems

# 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
- Contact: Ms. Ruoli Mo 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: CHISON Q8/Q6/ Roll (Portable) Diagnostic Ultrasound System CHISON iVis 60 & iVis 60 EXPERT/i7 (roll-around) Diagnostic Ultrasound System

Common/Usual Name: Diagnostic Ultrasound System with Accessories

Classification: Regulatory Class: II Review Category: Tier II

| Classification 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:

K101236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System

#### 3. Device Description:

The CHISON Q6 / Q8 / iVis60 / iVis60 / EXPERT / i7 ultrasound system is an integrated preprogrammed color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

TAB 20

510(k) Summary

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The CHISON ultrasound system can be configured either as a portable model (Q6/Q8), or as a roll-around model on wheels (iVis60 / iVis60 EXPERT/i7). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years.

This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.

The CHISON Q Models and iVis60 Models and i7 Model, 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.

#### 4. Indications for Use:

The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for the evaluation of Fetal (Obstetrics), Abdomen, Cardiac (Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.

#### 5. Comparison to Predicate Device:

The CHISON Q Models and iVis60 Models and i7 Model are of comparable type and substantially equivalent to the current, GE Voluson E8 Diagnostic Ultrasound System (K101236). 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.

#### 6. Conclusion:

The CHISON Q Models and i7 systems are 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 and Doppler capabilities. 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.

TAB 20

# 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centrally aligned. The words are capitalized, and the overall appearance is clean and professional.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

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

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

JUN 1 4 2012

Re: K120801

Trade/Device Name: CHISON iVis 60EXPERT, O 6/08. i7 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 · Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 18, 2012 Received: May 22, 2012

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the CHISON iVis 60EXPERT, Q 6/Q8, i7 Diagnostic Ultrasound Systems, as described in your premarket notification:

## Transducer Model Number

D3C60L Convex Array D4C40L Convex Array D5C20L Convex Array D6C12L Micro-convex Array D7C10L Micro-convex Array D6C15L Convex Array D7L30L Linear Array

D7L60L Linear Array D7L40L Linear Array D3P64L Phased Array D6P64L Phased Array V4C40L Convex Array D10L40L Linear Array

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely Yours.

Richard D. O'Kane for

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Diagnostic Ultrasound Indications For Use

# 1.3 Indications for Use

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal (Obstetrics),Abdomen, Cardiac(Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculoskeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.

---

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety 510K

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eva ustion (ODE)

Indications For Use

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# Diagnostic Ultrasound Indications For Use

#### CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

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

| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------------------------------|---------------------------------|---|-------------------|-----|-----|-------------------------------|------------------|----------|-------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N | |
| | Abdominal | N | N | N | N | N | N | Note 1 | N | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | N | |
| | Small Organ[1] (Specify) | N | N | N | | N | N | Note 1 | N | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | N | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 | N | |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1 | N | |
| | Intravascular | | | | | | | | | |
| | Other(Urology) | N | N | N | | N | N | Note 1 | N | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | N | |
| | 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 PWD, B+Power Doppler+PWD, B+Power Doppler+PWD Other *: 3-D · 4-D, Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

Additional Comments:

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

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

*Concurrence of CDRH, Office of Device Evaluation (ODE)*

*(Division Sign-Off)*

*Division of Radiological Devices*

*Office of In Vitro Diagnostic Device Evaluation and Safety*

| Section 510(k) | K120801 |
|----------------|---------------------|
| | Indications For Use |

Page 2 of 15

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Chison Medical Imaging Co., Ltd. - iVis 60 & Q Series,i7 Diagnostic Ultrasound Systems CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D3C60L 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>Doppler | Combined | Other* | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N | |
| | Abdominal | N | N | N | | N | N | Note 1 | N | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ1 (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 | N | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N = new indication; R = previously cleared by FDA; | | | | | E = added under this appendix | | | | |

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+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging. [1] Small Organ: Thyroid, testes and breast etc.

Additional Comments:

Prescription Use ✓
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120801

Section 1.3 Indications For Use Page 3 of 15

Section 1.3

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Chison Medical Imaging Co., Ltd. - iVis 60 & Q Series.i7 Diagnostic Ultrasound Systems System: CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems Transducer: D4C40L 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>Doppler | Combined | Other* |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N |
| | Abdominal | N | N | N | | N | N | Note 1 | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ1 (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 | N |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| 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 | | | |

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+Color Doppler+PWD, B+Power Doppler+PWD Other *: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

**Additional Comments:**

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

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

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K120801 |
|------|---------|
|------|---------|

| Section 1.3 | Indications For Use | Page 4 of 15 |
|-------------|---------------------|--------------|
|-------------|---------------------|--------------|

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

CHISON iVis 60/ iVis 60EXPERT. Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D5C20L Convex Array

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|------------------|----------|--------|
| | | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined | Other* |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal<br>Abdominal | N | N | N | N | N | N | Note 1 | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | N |
| | 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 | N | Note 1 | N |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | N |
| | 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+Color Doppler+PWD. B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

Additional Comments:

Prescription Use ✓
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Secti510K3 K120801

Indications For Use

Page 5 of 15

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

CHISON iVis 60/ iVis 60EXPERT. Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D6C12L Micro-convex Array

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|-----|------------------|------------------|----------|--------|
| | | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined | Other* |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | |
| 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 | N | N | N | | N | N | Note 1 | N |
| | Trans- urethral | | | | | | | | |
| | Trans- esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other(Urology) | N | N | N | | N | N | Note 1 | N |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| 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:

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+PWD. B+Power Doppler+PWD Other *: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

Additional Comments:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510K. K120801
Section 1.3 Indications For Use Page 6 of 15

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System: CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems Transducer: D7C10L 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>Doppler | Combined | Other |
| 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 | | N | N | N | | N | N | Note 1 | N |
| | Trans-urethral | | | | | | | | | |
| | Trans- esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other(Urology) | | N | N | N | | N | N | Note 1 | N |
| | Other (Ob/GYN) | | N | N | N | | N | N | Note 1 | N |
| 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:

Note 1: B+M. B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

Additional Comments:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510K | K120801 | |
|-------------|---------------------|--------------|
| Section 1.3 | Indications For Use | Page 7 of 15 |

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System: CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems Transducer: D6C15L 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>Doppler | Combined | Other* |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | N |
| | Abdominal | N | N | N | | N | N | Note 1 | N |
| | 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) | N | N | N | | N | N | Note 1 | N |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | N |
| 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:

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+PWD. B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

| Prescription Use <span style="text-decoration: overline;">√</span><br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use <span style="text-decoration: overline;"></span><br>(21 CFR 801 Subpart C) |
|---------------------------------------------------------------------------------------------------|--------|-------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------|--------|-------------------------------------------------------------------------------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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

Section 1.3

Indications For Use

Page 8 of 15

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CHISON iVis 60/ iVis 60EXPERT. Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D7L30L 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>Doppler | Combined | Other* |
| 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) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1 | N |
| | Intravascular | | | | | | | | |
| | Other(Urology) | | | | | | | | |
| | 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 | | | | | | | | |

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+PWD. B+Power Doppler+PWD. Other *: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

Prescription Use ✓
AND/OR
Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120801

Section 1.3

#### Indications For Use

Page 9 of 15

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CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D7L60L Linear Array

| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------|---------------------------------|--------------------------------|---|-----|-----|-------------------------------|---------|----------|--------|
| | | | | | | | | | |
| General | Specific | B | M | PWD | CWD | Color | Power | Combined | Other* |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | Doppler | Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging & | Fetal | | | | | | | | |
| Other | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | N |
| | Small Organ[1] (Specify) | N | N | N | | N | N | Note 1 | N |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans- rectal | | | | | | | | |
| | Trans- vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans- esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | 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 | N |
| | Other (Specify) | | | | | | | | |
| | N = new indication; | P = previously cleared by FDA; | | | | E = added under this appendix | | | |

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+Color Doppler+PWD. B+Power Doppler+PWD Other *: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K120801

9

Section 1.3

#### Indications For Use

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

#### CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems System: Transducer: D7L40L 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>Doppler | Combined | Other* |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | N |
| | Small OrganII (Specify) | N | N | N | | N | N | Note 1 | N |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans- rectal | | | | | | | | |
| | Trans- vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans- esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | 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 | N |
| | Other (Specify) | | | | | | | | |
| | N = new indication;<br>P = previously cleared by FDA; | | | | | E = added under this appendix | | | |

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+Color Doppler+PWD, B+Power Doppler+PWD Other*: Tissue Harmonic Imaging, [1] Small Organ: Thyroid, testes and breast etc.

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

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

| (Division Sign-Off)<br>Division of Radiological Devices<br>Office of In Vitro Diagnostic Device Evaluation and Safety<br>510K | K120801 | |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------|
| Section 1.3 | Indications For Use | Page 11 of 15 |

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

#### CHISON iVis 60/ iVis 60EXPERT, Q 6/Q8,i7 Diagnostic Ultrasound Systems System: D3P64L Phased Array Transducer:

| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------------|--------------------------------------|---|-------------------|-----|-----|---------------|---------------|----------|--------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Power Doppler | Combined | Other* |
| 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 | | | | | | | | |
|…