Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with image processing capabilities, but there is no mention of AI, ML, or related terms.

Therapeutic

No
The device is described as a diagnostic ultrasound imaging system, used for evaluation and acquiring ultrasound echo data, not for treating or preventing disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and the "Device Description" states "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." and "This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed ultrasound imaging system" and a "portable model," indicating it includes 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:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body.
Device Function: The description clearly states that this is an ultrasound system used for diagnostic ultrasound imaging or fluid flow analysis of the human body. It acquires ultrasound echo data and displays images of anatomical structures and fluid flow within the body.
Intended Use/Indications for Use: The listed applications (Abdomen, Cardiac, Small Organ, etc.) are all procedures performed on a living patient, not on samples taken from a patient.

Therefore, this device falls under the category of medical imaging devices used for in-vivo (within the living body) diagnosis, not in-vitro diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Urology, Ob/GYN, Cardiac Pediatric, Peripheral vessel.
For V6, 6.0MHz Micro-convex Array Transducer: Trans-vaginal, Urology, Ob/GYN.
For L7M, 7.5MHz Linear Array Transducer: Pediatric, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast), Musculo-skeletal (Conventional and Superficial), Peripheral vessel.
For L7S, 7.5MHz Linear Array Transducer: Pediatric, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast), Musculo-skeletal (Conventional and Superficial), Peripheral vessel.
For R7, 7.5MHz Linear Array Transducer: Trans-rectal, Urology.

Product codes (comma separated list FDA assigned to the subject device)

90-IYO, 90-ITX

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. 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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.

Indicated Patient Age Range

Not Found

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

A6 Portable Ultrasonic Diagnostic System (no K/DEN provided)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

0

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.

1

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.

2

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

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 (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

4

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	✓	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

5

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
(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			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
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
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
Indications For Use		Page 2 of 8

6

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)	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)

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
(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			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
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
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	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)
Concurrence of CDRH, Office of Device Evaluation (ODE)

	Office of in Vitro 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
(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			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
Note 3	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &
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
Note 3	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined
General
(Track 1 Only)	Specific
(Tracks 1 & 3)
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			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