A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

• K Number: K101337
• Device Name: A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2010-09-30 ( 141 days)
• Product Code: IYO
• Regulation Number: 892.1560

Intended Use

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging 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. This device is intended to adult, pregnant woman, pediatric, and neonate.

Device Description

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.

Predicate Devices

K070526, K041455, K052042

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology and modes.

Therapeutic

No.
The device is described as a "general-purpose ultrasonic imaging instrument" and a "diagnostic system" used for evaluation, implying it is for imaging and diagnosis, not for treating conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "a general-purpose ultrasonic imaging instrument intended 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." This evaluation is a diagnostic activity.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Portable Ultrasonic Diagnostic System with added transducer" and mentions projecting ultrasound waves and presenting returned echo information, which are hardware functions. It also mentions employing an array of probes.

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.
• Device Function: The A6 Portable Ultrasonic Diagnostic System is described as an "ultrasonic imaging instrument" that uses ultrasound waves to create images of internal body structures. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states it's for "evaluation of Abdomen, Cardiac, Small Organ... Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal... Pediatric, Fetal, OB/Gyn and Urology." These are all applications of in vivo (within the living body) imaging.

Therefore, the A6 Portable Ultrasonic Diagnostic System is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging 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. This device is intended to adult, pregnant woman, pediatric, and neonate.

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

IYO, ITX

Device Description

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.

Mentions image processing

Not Found

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

Adult, pregnant woman, pediatric, and neonate.

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)

Laboratory testing was conducted to verify that the A6 Portable Ultrasonic Diagnostic System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".
No clinical testing was required.

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.

K070526, K041455, K052042

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

Tab 20 PREMARKET NOTIFICATION 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Date of submission: 03 SEPT 2010

Submitter:

SonoScape Company Limited

Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China

Tel: [phone]

Fax: [phone]

Contact Person: Zhiqiang Chen

Name of the device:

.

• Trade/Proprietary Name: A6 Portable Ultrasonic Diagnostic System

• Common Name: Diagnostic Ultrasound System and Transducers * Classification:

Regulatory Class: II

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-1TX)

Legally Marketed Predicate Device:

K070526, DP-9900 Digital Ultrasonic Diagnostic Imaging System K041455, SSI-600 Portable Diagnostic Ultrasound System K052042, SSI-1000 Portable Color Doppler Ultrasound System

1

Description:

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.

Statement of intended Use:

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging 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. This device is intended to adult, pregnant woman, pediatric, and neonate.

Technological Characteristics:

The A6 Portable Ultrasonic Diagnostic System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 1 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9,2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. All transducers used with the A6 Portable Ultrasonic Diagnostic System are track 1. All patient contact materials are biocompatible. The technology characteristics of the A6 Portable Ultrasonic Diagnostic System with these modifications do not affect the safety or efficacy of the device.

Testing:

Premarket Notification 510(k) Summary

20-2

2

SonoScape Company LTD

Laboratory testing was conducted to verify that the A6 Portable Ultrasonic Diagnostic System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

Standards No.	Standards Title	Version	Date
IEC 60601-1	IEC 60601-1, Medical Electrical Equipment - Part 1:
General Requirements for Safety, 1988; Amendment 1,
1991-11, Amendment 2, 1995.	1988	10/31/2005
IEC 60601-1-2	IEC 60601-1-2, (Second Edition, 2001), Medical
Electrical Equipment - Part 1-2: General Requirements
for Safety - Collateral Standard: Electromagnetic
Compatibility -- Requirements and Tests.	2001	07/31/2008
IEC
60601-2-37	IEC 60601-2-37 (2004) (2005) Amendment 2, Medical
electrical equipment - Part 2-37: Particular requirements
for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment.	2004	09/08/2009
NEMA UD 2	NEMA UD 2-2004, Acoustic Output Measurement
Standard for Diagnostic Ultrasound Equipment Version 3.	2004	09/08/2009
ISO 10993-5	ISO 10993-5:1999, Biological evaluation of medical
devices - Part 5: Tests for In Vitro cytotoxicity.	1999	09/12/2007
10993-10	ISO 10993-10:2002, Biological evaluation of medical
devices - Part 10: Tests for irritation and delayed-type
hypersensitivity.	2002	09/12/2007

Tab 20.1 Applicable Safety Standards

Clinical Test:

No clinical testing was required

Conclusion:

The conclusions drawn from testing of the A6 Portable Ultrasonic Diagnostic System with

added transducer demonstrates that the devices as safe, as effective as well as the

legally marketed predicate devices.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

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

SonoScape Company Limited % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K101337

SEP 3 0 2010

Trade/Device Name: A6 Portable Ultrasonic Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 16, 2010 Received: September 21, 2010

Dear Mr. Devine:

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 A6 Portable Ultrasonic Diagnostic System, as described in your premarket notification:

Transducer Model Number

6V4 Micro-curved Array 6V5 Micro-curved Array EC2 Micro-curved Array BCC9-4 Micro-curved Array C612 Micro-curved Array C312 Mirco-curved Array

C351 Curved Array C352 Curved Array C543 Curved Array L745 Linear Array L746 Linear Array

4

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 Shahram Vaezy at [phone].

Sincerely yours,

Sincerely yours,

David C. Rowe, Ph.D.

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

A6 Portable Ultrasonic Diagnostic System

Tab 3 Indications For Use

· 510(k) Number: K101337

Device Name: A6 Portable Ultrasonic Diagnostic System

SEP 3 0 2010

Indications for Use:

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging 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. This device is intended to adult, pregnant woman, pediatric, and neonate.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K101337

6

System: Sonoscape A6 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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	N	N					Note 1	Note 2
	Abdominal	N	N					Note 1	Note 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N					Note 1	Note 2
	Small Organ (specify)	N	N					Note 1	Note 2,3
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N					Note 1	Note 2
	Trans-vaginal	N	N					Note 1	Note 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	N	N					Note 1	Note 2, 3
	Musculo-skeletal
(Superficial)	N	N					Note 1	Note 2, 3
	Intravascular
	Other (Urology)	N	N					Note 1	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
Cardiac	Cardiac Adult	N	N					Note 1	Note 2
	Cardiac Pediatric	N	N					Note 1	Note 2
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N					Note 1	Note 2
	Other (specify)

N = new indication; Note 1: B/M

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

P = previously cleared by FDA;

Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

(Division Sign-Off)

E = added under this appendix

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101337

7

Transducer: 6V4 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)
Cardiac	Other (Ob/GYN)	N	N					Note 1	Note 2
	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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

.

(Division Sign-Off)

(Division of Radiological Devices Division of Radiological Devices Evaluation and Safety

510K K106337

8

Transducer: 6V5 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N					Note 1	Note 2
	Trans-vaginal	N	N					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	N	N					Note 1	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K101332
510K

9

Transducer: EC2 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N					Note 1	Note 2
	Trans-vaginal	N	N					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	N	N					Note 1	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
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

N = new indication;

• new indication,

Note 1: B/M Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

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

510K K101337

10

Transducer: BCC9-4 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
Abdominal
Intra-operative Specify
Intra-operative Neuro
Laparoscopic
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N					Note 1	Note 2
	Trans-vaginal	N	N					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	N	N					Note 1	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

__, the one that is.

Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety

K10133-7
510K

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Transducer: C612 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
Abdominal	N	N					Note 1	Note 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N					Note 1	Note 2
	Small Organ (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	Note 2
	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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

કાબ્દ

(Division Sign-Off)
Division of Radiological Devices
untic Device Evaluation and Safety

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety

.

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Transducer: C312 Micro-curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
Abdominal
Intra-operative Specify
Intra-operative Neuro
Laparoscopic
Pediatric
Small Organ (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
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra-cardiac
Other (specify)	N	N					Note 1	Note 2
Peripheral
Vessel	Peripheral vessel
Other (specify)

N = new indication;

indication;

P = previously cleared by FDA;

E = added under this appendix

Note 1: B/M

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

signature

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

510K K101337

13

Transducer: C351 Curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	N	N					Note 1	Note 2
	Abdominal	N	N					Note 1	Note 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (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	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

(Division Sign-Off)

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

K101337
510K

:

14

Transducer: C352 Curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	N	N					Note 1	Note 2
	Abdominal	N	N					Note 1	Note 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (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	Note 2
	Other (Ob/GYN)	N	N					Note 1	Note 2
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

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

(Division Sign-Off)

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

510K K101337

15

Transducer: C543 Curved Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal	N	N	N				Note 1	Note 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N				Note 1	Note 2
	Small Organ (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
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

N = new indication;

Note 1: B/M

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

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

510K K101337

16

Transducer: L745 Linear Array Diagnostic Ultrasound Transducer

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	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
Abdominal
Intra-operative Specify
Intra-operative Neuro
Laparoscopic
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	N	N					Note 1	Note 2,3
	Musculo-skeletal
(Superficial)	N	N					Note 1	Note 2,3
	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	Note 2
	Other (specify)

N = new indication;

P = previously cleared by FDA;

510K

E = added under this appendix

Note 1: B/M

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

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

Indications for use

·

17

Transducer: L746 Linear Array Diagnostic Ultrasound Transducer

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	Other*
Specify.
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
Abdominal
Intra-operative Specify
Intra-operative Neuro
Laparoscopic
Pediatric
Small Organ (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)	N	N					Note 1	Note 2,3
Cardiac	Cardiac Adult
Cardiac Pediatric
Intravascular(Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (specify)
Peripheral
Vessel	Peripheral vessel	N	N					Note 1	Note 2
	Other (specify)

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note 1: B/M

Note 2: THI (Tissue Harmonic Imaging). The feature does not use contrast agents.

Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

signature

(Division Sign-Gify Division of Radiological Devices - Emotor of Nationogical Devices
Vitro Diagnostic Device Evaluation and Safety

510K K10/32-