CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
Device Facts
| Record ID | K112539 |
|---|---|
| Device Name | CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE |
| Applicant | Leiker Regulatory & Quality Consulting |
| Product Code | IYO · Radiology |
| Decision Date | Jan 30, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The system is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
Device Story
SONO TOUCH Series is a portable, software-controlled diagnostic ultrasound system. It acquires ultrasound echo data via various transducers (convex, micro-convex, linear arrays) and displays images in B-Mode (including Tissue Harmonic Imaging) and M-Mode. Operated by qualified physicians in clinical settings, the device transforms received echoes into real-time anatomic and fluid flow visualizations. Clinicians use these images and integrated measurement/calculation tools to evaluate structures and flow, aiding in diagnostic decision-making across multiple clinical applications. The system provides high-detail resolution imaging to assist in patient assessment.
Clinical Evidence
Bench testing only. The device was evaluated for compliance with safety standards including NEMA UD 2 (acoustic output), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic safety), and ISO 10993-1 (biocompatibility). No clinical data was required for this 510(k) submission.
Technological Characteristics
Portable ultrasound system; B-Mode and M-Mode operation; includes Tissue Harmonic Imaging. Transducers: C3 (3.5 MHz convex), MC3 (3.0 MHz micro-convex), V6 (6.0 MHz micro-convex), L7M/L7S (7.5 MHz linear), R7 (7.5 MHz linear). Safety standards: NEMA UD 2, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound imaging and fluid flow analysis of the abdomen, heart, small organs (thyroid, parathyroid, parotid, submaxillary gland, testes, breast), peripheral vessels, transvaginal, transrectal, musculoskeletal (conventional/superficial), pediatric, fetal, OB/Gyn, and urology applications.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- A6 Portable Ultrasonic Diagnostic System
Submission Summary (Full Text)
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JAN 3 0 2012
# 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
- Contact: Ms. Ruoli Mo Tel: +86-510-85311707, 85310593
Fax: +86-510-85310726
U.S. Agent: Leiker Regulatory & Quality Consulting 7263 Cronin Circle Dublin, CA 94568
Contact: Bob Leiker Tel: (925) 556-1302 Fax: (866) 718-3819
- Device Name: SONO TOUCH Series (Portable) Diagnostic Ultrasound System રાં
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 echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
## 2. Marketed Device:
A6 Portable Ultrasonic Diagnostic System
## 3. Device Description:
The SONO TOUCH Series ultrasound system is an integrated preprogrammed ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The CHISON ultrasound system is configured as a portable model (SONO TOUCH Series). 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.
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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, or a combination of these modes.
The SONO TOUCH Series Models, have been designed to meet the following product safety standards: NEMA UD 2, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.
## 4. Indications for Use:
The system is a general-ourpose ultrasonic imstrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal.Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
# Comparison to Predicate Device:
The SONO TOUCH Series Models is of comparable type and substantially equivalent to the A6 Portable Ultrasonic Diagnostic 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 SONO TOUCH 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Chison Medical Imaging CO., Ltd. % Mr. Bob Leiker U.S. Agent Leiker Regulatory & Quality Consulting 7263 Cronin Circle DUBLIN CA 94568
MAR – 8 2012
Re: K112539
Trade/Device Name: SONOTOUCH Series (Portable) Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: January 14, 2012 Received: January 18, 2012
Dear Mr. Leiker:
This letter corrects our substantially equivalent letter of February 1, 2012.
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 SONOTOUCH Series (Portable) Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C3, 3.5 MHz Convex Array MC3, 3.0MHz Micro-convex Array V6, 6.0MHz Micro-convex Array
L7M. 7.5MHz Linear Array L7S, 7.5MHz Linear Array R7. 7.5MHz Linear Array
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.
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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.
Sincerely Yours.
Mary Slatsel 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 The "Go 10" is "a general of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, paronectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
| Prescription Use | <span style="text-decoration: underline;">✓</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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mary S Patel | (Division Sign-Off) |
|------------------------------------------------------------|---------------------|
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K112539 |
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# Diagnostic Ultrasound Indications For Use
### System:
SONO TOUCH Series Diagnostic Ultrasound Systems Diagnostic Ultrasound Pulsed Echo 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 | | | | | Note 1 |
| | Abdominal | N | N | | | | | Note 1 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | Note 1 |
| | Small Organ(1) (Specify) | N | N | | | | | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | | | | | Note 1 |
| | Trans-vaginal | N | N | | | | | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | | | | | Note 1 |
| | Musculo-skeletal (Superficial) | N | N | | | | | Note 1 |
| | Intravascular | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 |
| | Other (Ob/GYN) | N | N | | | | | Note 1 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | N | N | | | | | Note 1 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | | | | | Note 1 |
| | Other (Specify) | | | | | | | |
| 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 | N | N | | | | | Note 1 |
| Other | Abdominal | 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) | N | N | | | | | Note 1 |
| | Other (Ob/GYN) | 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 | | | | | | | | |
| Comments: | | | | | | | | |
| | Small Organ: Thyroid, parathyroid, parotid.submaxillary gland, testes and breast | | | | | | | |
| 17634111111111 Vor | | | |
|-----------------------------|--------------------------------------------------------------------------|------------------------------------------------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |
| | | | |
| | (PLEASE DO NOT WRITE BETTY/THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | |
| | | nce of CDRH. Office of Device Evaluation (ODE) | |
| | Division of Radiological Devices | | |
| | Office of In Vitro Diagnostic Device Evaluation and Sefety | | |
| | | | |
| Section 1.3 | Elok<br>Indications For Use | | Page 2 of 8 |
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#### Chison Medical Imaging Co., Ltd.
#### SONO TOUCH Series Ultrasound Systems System: C3, 3.5 MHz Convex Array Transducer:
# Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Additional Comments:
| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="text-align:center;">AND/OR</div> | 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)
Mary S. Patil
(Division Sign-Off)
Radiological Devices
stic Device Evaluation and Safety
K112539
{7}------------------------------------------------
| System: | SONO TOUCH Series Ultrasound Systems |
|-------------|--------------------------------------|
| Transducer: | MC3, 3.0MHz 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 &<br>Other | Fetal | | | | | | | |
| | Abdominal | N | N | | | | | Note 1 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | Note 1 |
| | 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) | | | | | | | |
| | Other (Ob/GYN) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | 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:
Comments:
Small Organ: Thyroid, parathyroid, parotid,submaxillary gland, testes and breast
# 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)
Mary S Patil
---
(Division Sign-Off)
(Division of Radiologics) (Division Sign-Oli ce Evaluation and Safety 8 Becken T
{8}------------------------------------------------
### Chison Medical Imaging Co., Ltd.
#### SONO TOUCH Series Ultrasound Systems System: V6, 6.0MHz Micro-convex Array Transducer:
| Clinical Application | | | Mode of Operation | | | | | | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|--------|-----|------------------|---------------------------------|-------------------------------|--|--|
| | | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | | |
| 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 <sup>(1)</sup> (Specify) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | N | N | | | | | Note 1 | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Urology) | N | N | | | | | Note 1 | | |
| | Other (Ob/GYN) | 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 · | | | | | | | | | | |
| Comments: | | | | | | | | | | |
| | Small Organ: Thyroid, parathyroid, parotid,submaxillary gland, testes and breast | | | | | | | | | |
| 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)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | | | | | |
| | | | | | | | | | | |
| | Office of <i>in Vitro</i> Diamostic Device Evaluation and Safety | | | | | | | | | |
# Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Section 19%
{9}------------------------------------------------
SONO TOUCH Series Ultrasound Systems System: Transducer: L7M, 7.5MHz 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 | | | | | Note 1 |
| | Small Organ1 (Specify) | N | N | | | | | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | | | | | Note 1 |
| | Musculo-skeletal (Superficial) | 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 | | | | | Note 1 |
| | 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 Comments: Small Organ: Thyroid, parathyroid, parotid,submaxillary gland, testes and breast Additional Comments:
Over-The-Counter Use AND/OR Prescription Use 1 (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpari D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) currence of CDRII, Office of Device Evaluation (ODE)
Mary S. Padle
(Division Sign-Off)
Division of Radiological Devices
ostic Device Evaluation and Sefety Office of In Vitro Diagn
2100
Indications For Use
Page 6 of 8
{10}------------------------------------------------
#### Chison Medical Imaging Co., Ltd.
#### SONO TOUCH Series Ultrasound Systems System: L7S, 7.5MHz Linear Array Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|---------------|------------------|---------------------------------|--------------------|
| | | B | M | PWD | CWD<br>Note 3 | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined |
| 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 | N | N | | | | | Note 1 |
| | Small Organ (1)(Specify) | N | N | | | | | Note 1 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | N | N | | | | | Note 1 |
| | Musculo-skeletal (Superficial) | 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 | | | | | 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;
Note 1: B/M Comments: Small Organ: Thyroid, parathyroid, parotid,submaxillary gland, testes and breast 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)
Mary S Pastil
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Rediological Devices stic Device Evaluation and Safety Office of in Vitro Diagno Special 1
{11}------------------------------------------------
#### SONO TOUCH Series Ultrasound Systems System: R7, 7.5MHz Linear Array Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------|-------------------|---|-----|---------------|------------------|---------------------------------|--------------------|
| | | B | M | PWD | CWD<br>Note 3 | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined |
| 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 | N | N | | | | | Note 1 |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Urology) | 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) | | | | | | | |
# Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: B/M Comments: Comments:
Small Organ: Thyroid, parathyroid, parotid,submaxillary gland, testes and breast 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)
*Mary S. Pastel*
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K112539
Section 1.3
Indications For Use
Page 8 of 8
