SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS

• K Number: K121867
• Device Name: SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
• Manufacturer: CHISON MEDICAL IMAGING CO., LTD.
• Date Cleared: 2012-08-02 ( 37 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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 Description

The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating 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. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.

Predicate Devices

K102256

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and digital processing, with no mention of AI, ML, or related concepts like training or test sets for algorithmic performance.

Therapeutic

No
The device is described as an ultrasonic imaging instrument used for evaluation and display of anatomical structures, not for treating any condition.

Diagnostic

Yes

The device is an ultrasonic imaging instrument intended for use by a qualified physician for evaluation of various anatomical sites (Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Musculoskeletal, Transrectal and Transvaginal). The phrase "evaluation of" strongly implies a diagnostic purpose. Additionally, the predicate devices are named "Diagnostic Ultrasound" systems, further confirming its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact and extremely portable ultrasound system consisting of a hand-carried console" and utilizes "interchangeable electronic-array transducers," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a general-purpose ultrasonic imaging instrument used by a qualified physician for the evaluation of various anatomical sites. This involves imaging structures within the body.
• Device Description: The description details an ultrasound system that uses transducers to generate images of internal structures and fluid flow.
• Mechanism: The device works by processing received echoes from within the body to create images.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.

IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose or monitor conditions. This device is an imaging modality used for direct visualization of internal structures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 Vasculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

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

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: C3, Convex Array:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Abdominal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Other (Urology) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Other (Ob/GYN) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: MC3, Micro-convex Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Abdominal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Cardiac Adult (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Cardiac Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: V6, Micro-convex Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Trans-rectal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Trans-vaginal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Other (Urology) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Other (Ob/GYN) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: L7M, Linear Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Small Organ (Specify) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Conventional) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Superficial) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Peripheral vessel (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: L7S, Linear Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Small Organ (Specify) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Conventional) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Superficial) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Peripheral vessel (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: R7, Linear Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-rectal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Other (Urology) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: L7L, Linear Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Small Organ (Specify) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Conventional) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Musculo-skeletal (Superficial) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Peripheral vessel (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: P3, Phased Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Cardiac Adult (B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Cardiac Pediatric (B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: MC5V, Convex Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Abdominal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Cardiac Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD)

For the SonoTouch Series Diagnostic Ultrasound Systems, Transducer: MC6, Convex Array:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Pediatric (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Small Organ (Specify) (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)
Clinical Application: Peripheral vessel (B, M, PWD, Color Doppler, Power (Amplitude) Doppler, B+M, B+PWD, B+Color Doppler, B+Power Doppler PWD, B+Power Doppler+PWD, B+Power Doppler+PWD)

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating 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. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vasculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

Indicated Patient Age Range

Adult & Pediatric, Fetal

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102256, GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

SonoTouch Series Diagnostic Ultrasound System

AUG 2 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. Submitter: No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142

Contact:	Ms. Ruoli Mo
Tel: [phone]	Fax: [phone]

Date Prepared:May 22,2012

• Device Name: SonoTouch Series Diagnostic Ultrasound System 2.
  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:

K102256, GE LOGIQ e Uitrasound System

3. Device Description:

The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating 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. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are 这一次的一次的" រ និងប្រជាជា បានបាត A .. a " admal) Uleman

ت محمدر واقع آباد الموقع ಿ Attachment I

1

essential.

The SonoTouch 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.

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 Vasculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

Comparison to Predicate Device:

The SonoTouch Series Models is of comparable type and substantially equivalent to the GE LOGIQ i, LOGIQ e,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 SonoTouch 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.

1 Attachment I

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

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

AUG 2 2012

CHISON Medical Imaging Co., Ltd. % Mr. Michael S. Ogunleye Third Party Program Manager/Lead Medical Auditor TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K121867

Trade/Device Name: SonoTouch Series 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: July 25, 2012 Received: July 25, 2012

Dear Mr. Ogunleve:

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 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

C3. Convex Array MC3. Micro-convex Array V6, Micro-convex Array L7M, Linear Array L7S, Linear Array

R7, Linear Array L7L, Linear Array P3, Phased Array MC5V, Convex Array MC6. Convex 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,

Michael D. O'Hern 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

4

SonoTouch Series Diagnostic Ultrasound Systems

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/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

---

(Division Sign-Off)
Division of Radiological Devices
12/2/2020 DIVD**

AND/OR Prescription Use V 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) ence of CDRH, Office of Device Evaluation (ODE) 11 0

Indications For Use

-2 315 - 1

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Diagnostic Ultrasound Indications For Use

System: SonoTouch Series Diagnostic Ultrasound Systems

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

	Clinical Application		Mode of Operation
	General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
	Ophthalmic	Ophthalmic
Fetal Imaging &
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 (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	N	Note 1
	Cardiac Pediatric	N	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+Color Doppler+PWD, B+Power Doppler+PWD 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

510k	K121889
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Section 1.3	Indications For Use	Page 2 of 12
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SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: C3, Convex Array

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

Clinical Application			Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
Ophthalmic	Ophthalmic
Fetal Imaging &
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)

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+Color Doppler+PWD, B+Power Doppler+PWD Comments:

Small Organ: Thyroid, testes and breast

Additional Comments:

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

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

(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Radiological Devices

510k K121867

Section 1.3	Indications For Use	Page 3 of 12
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System: SonoTouch Series Diagnostic Ultrasound Systems Transducer: MC3, Micro-convex Array

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

	Clinical Application	Mode of Operation
		B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	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)

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

Small Organ: Thyroid, 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)

of CDRH, Office of Device Evaluation (ODE)

Division of Radiological Devices

Section 1.3	K821867
	Indications For Use

Page 4 of 12

8

SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: V6, Micro-convex Array

| Clinical Application | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation | | | | | | |
|---------------------------|---------------------------------|---|-----------------------------------------------------------------------------------------------------------------------|-----|-----|------------------|---------------------------------|--------------------|--|
| | | | | | | | | | |
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &
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 | | | | | | | | |

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

Other (Specify)

Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments: Small Organ: Thyroid, 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

510k Section 1.3 K121867

Indications For Use

Page 5 of 12

9

SonoTouch Series Diagnostic Ultrasound Systems

System: SonoTouch Series Diagnostic Ultrasound Systems Transducer: L7M, Linear Array

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

	Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
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			t
	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)
	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 Comments:

Small Organ: Thyroid, 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k K121867
Indications For Use

(1)

10

SonoTouch Series Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

SonoTouch Series Diagnostic Ultrasound Systems System: L7S, Linear Array Transducer:

Mode of Operation Clinical Application General Specific B M PWD CWD Color Power Other* (Track 1 Only) (Tracks 1 & 3) Doppler (Amplitude) Combined Doppler 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 N N N N Note-1 Musculo-skeletal (Superficial) 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 N N N N N Note 1 Other (Specify) P = previously cleared by FDA; E = added under this appendix N = new indication;

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 Comments: Small Organ: Thyroid, 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

510k

Section 1.3 Indications For Use Page 7 of 12

11

SonoTouch Series Diagnostic Ultrasound Systems System:

Transducer: R7, Linear Array

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD
Note 3	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	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
	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+Color Doppler+PWD, B+Power Doppler+PWD 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

510k	K121867
------	---------

Section 1.3	Indications For Use	Page 8 of 12
-------------	---------------------	--------------

12

System: SonoTouch Series Diagnostic Ultrasound Systems L7L, Linear Array Transducer:

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1
	Small Organ1 (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)

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 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)

(Division Sign-Off)

Division of Radiological Devices

510k	K121887
Section 1.3	Indications For Use	Page 9 of 12

13

SonoTouch Series Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: P3, Phased Array

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
Ophthalmic	Ophthalmic
Fetal Imaging &
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	N	Note 1
	Cardiac Pediatric	N	N	N	N	N	N	Note 1
	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+PWD, B+Power Doppler+PWD, B+Power Doppler+PWD

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)

(Division Sign-Off)

Division of Radiological Devices

510k K121867 QIVD

Section 1.3	Indications For Use	Page 10 of 12
-------------	---------------------	---------------

14

:

System: . SonoTouch Series Diagnostic Ultrasound Systems Transducer: MC5V, Convex Array

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

Clinical Application		Mode of Operation
		B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
	Ophthalmic
	Fetal
Other	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)
	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)

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 Comments:

Small Organ: Thyroid, 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)

(Division Sign-Off)

Division of Radiological Devices

510k K121867

Section 1.3	Indications For Use	Page 11 of 12
-------------	---------------------	---------------

15

SonoTouch Series Diagnostic Ultrasound Systems System: MC6, Convex Array Transducer:

Mode of Operation Clinical Application CWD Power Other* PWD Color Specific B M General Doppler (Amplitude) Combined (Tracks 1 & 3) (Track 1 Only) Doppler Ophthalmic Ophthalmic Fetal Fetal Imaging & N N Note 1 N N N Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Note 1 N N N N N Pediatric Small Organ (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 Adult Cardiac Note 1 N N N Z Cardiac Pediatric N Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) N N N N Note 1 Peripheral Vessel Peripheral vessel N Other (Specify) P = previously cleared by FDA; E = added under this appendix N = new indication;

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, B+Power Doppler+PWD Comments:

Small Organ: Thyroid, 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)

(Division Sign-Off)

Division of Radiological Devices

510k K121867

Indications For Use