PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

• K Number: K123616
• Device Name: PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2012-12-21 ( 28 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, submaxillar, gland, testes and breast.), Peripheral Vascular, Trans-vaginal, Trans-rectal, 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 and 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 and 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

K101337

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on standard ultrasound imaging modes and hardware.

Therapeutic

No
The device is an ultrasonic diagnostic system, meaning it is used for imaging and diagnosis, not for treating conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "The A6 Portable Ultrasonic Diagnostic System...is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of [various anatomical sites]." The term "evaluation" within a medical context for an imaging instrument directly indicates a diagnostic purpose. The device is also described as a "diagnostic system" in the Device Description.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable, software controlled and ultrasound diagnostic system" and mentions "an array of probes that include linear array and convex linear array". This indicates the device includes hardware components (the ultrasound system itself and the transducers/probes) in addition to 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.
• Device Function: The description clearly states that the A6 Portable Ultrasonic Diagnostic System is an "ultrasonic imaging instrument" that "projects ultrasound waves into body tissue and to present the returned echo information on the monitor." This is an in vivo (within the living body) diagnostic method, not an in vitro one.
• Intended Use: The intended use describes imaging various anatomical sites within the body.
• Device Description: The description focuses on the ultrasound technology and how it interacts with body tissue.

Therefore, the A6 Portable Ultrasonic Diagnostic System is a diagnostic imaging device that operates in vivo, 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 t 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 and 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 and 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, 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 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".

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.

K101337

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

K123616

SonoScape Company LTD

A6 Portable Ultrasonic Diagnostic System

Tab 4 510(k) Summary

DEC 2 1 2012

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:

Date of submission: November 15, 2012

Submitter:

SonoScape Company Limited

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

Tel: [phone]

Fax: [phone]

Contact Person: Zhou Wenping

Submission Correspondent:

Ms. Diana Hong & Mr. Lee Fu

Mid-Link Consulting Co., Ltd

P.O. Box 237-023, Shanghai, 200237, China

Tel: [phone]

Fax: [phone]

Email: [e-mail]

Proposed Device Identification:

• 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)

.

510(k) Summary

1

21 CFR 892.1570 Diagnostic Ultrasound Transducer(90-ITX)

Legally Marketed Predicate Device:

SonoScape A6 Portable Ultrasonic Diagnostic System 510(k) Number: K101337

Description:

The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled and 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 and 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.

Intended Use Statement:

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 t 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 Secking 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

: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Summary

2

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:

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 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". .....

IEC 60601-1; 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. IEC 60601-2-37: 2008 Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring i ..:.... ::::: . . . . . . . ... : .. .. equipment.

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

Clinical Test:

No clinical testing was required.

Substantially Equivalent Conclusion

The proposed device, A6 Portable Ultrasonic Diagnostic System, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.

510(k) Summary

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with stylized wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

SonoScape Company Limited % Ms. Diana Hong & Mr. Lee Fu General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023, Shanghai, 200237 CHINA

DEC 2 1 2012

Re: K123616.

Trade/Device Name: 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: November 23, 2012 Received: November 23, 2012

Dear Ms. Hong:

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 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 Micro-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,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

5

Tab 2 Indications for Use

510(k) Number: K123616

Device Name: Portable Ultrasonic Diagnostic System ·

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, submaxillar, gland, testes Vascular, Trans-vaginal, Trans-rectal, Musculo-skeletal and breast.), Peripheral (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123616

Tab 2 Indications for use

6

System: SonoScape A6 Diagnostic Ultrasound Pulsed Echo System

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

| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | Mode of Operation | | | | | | Other* | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|----------|----------|
| | | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging&
Other | Fetal
Abdominal | P | P | | | | | Note 1 | Note 2 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | | | | | Note 1 | Note 2 |
| | Small Organ (specify) | P | P | | | | | Note 1 | Note 2,3 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | | | | | Note 1 | Note 2 |
| | Trans-vaginal | P | P | | | | | Note 1 | Note 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | P | P | | | | | Note 1 | Note 2 |
| | Musculo-skeletal
(Superficial) | P | P | | | | | Note 1 | Note 2 |
| | Intravascular | | | | | | | | |
| | Other (Urology) | P | P | | | | | Note 1 | Note 2 |
| | Other (Ob/GYN) | P | P | | | | | Note 1 | Note 2 |
| Cardiac | Cardiac Adult | P | P | | | | | Note 1 | Note 2 |
| | Cardiac Pediatric | P | P | | | | | Note 1 | Note 2 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | | | | | Note 1 | Note 2 |

N = new indication;

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 Health

Tab 2 Indications for use

Office of In Vitro Diagnostics and Radiological Health

510(K) K123616

7

6V4 Micro-curved Array Transducer: 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	P	P					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)
	Other (Ob/GYN)	P	P					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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

Sammy Thomas
(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) K123616

8

6V5 Micro-curved Array Transducer: 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	P	P					Note 1	Note 2
	Trans-vaginal	P	P					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	P	P					Note 1	Note 2
	Other (Ob/GYN)	P	P					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.

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

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and R

2-4

510(k) K123616

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						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	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	P	P					Note 1	Note 2
	Trans-vaginal	P	P					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	P	P					Note 1	Note 2
	Other (Ob/GYN)	P	P					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.

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

(Division Sign Off)

Division of Radiological Health

Indications for use

Office of In Vitro Diagnostics and Radiological Health

510(k) K123616

10

BCC9-4 Micro-curved Array Transducer: 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	P	P					Note 1	Note 2
	Trans-vaginal	P	P					Note 1	Note 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Urology)	P	P					Note 1	Note 2
	Other (Ob/GYN)	P	P					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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

(Division Sign Off)

Division of Radiological Health

Indications for use

Office of In Vitro Diagnostics and Radiological Health

510(k) K123616

11

C612 Micro-curved Array Transducer: 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	P	P					Note 1	Note 2
	Intra-operative Specify
Intra-operative Neuro
	Laparoscopic
Pediatric
Small Organ (specify)	P	P					Note 1	Note 2
	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	P	P					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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

(Division Sign Off)

Indications for use

Division of Radiological Health ാനിറേ of In Vitro Diagnostics and Radiological Health

510(k) K123616

12

C312 Micro-curved Array Transducer: 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)	P	P	P				Note 1	Note 2
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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

Sam Thain
(Division Sign Off)

Division of Radiological Health

Office of in Vitro Diagnostics and

510(k) K123616

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	P	P					Note 1	Note 2
	Abdominal	P	P					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)	P	P					Note 1	Note 2
	Other (Ob/GYN)	P	P					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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

Danu Than
(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiolo

510(k) K123616

2-9

14

C352 Curved Array Transducer: 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	P
P	P
P					Note 1
Note 1	Note 2
Note 2
	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)	P
P	P
P					Note 1
Note 1	Note 2
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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radio

510(k) K123616

2-10

15

C543 Curved Array Transducer: 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	P	P					Note 1	Note 2
		Intra-operative Specify
		Intra-operative Neuro
		Laparoscopic
		Pediatric	P	P					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)
Cardiac		Intravascular
		Other (Urology)
		Other (Ob/GYN)
		Cardiac Adult
		Cardiac Pediatric
		Intravascular(Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral
Vessel		Other (specify)
		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. Note 3: Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.)

Dan Thom
(Division Sign Off)

División of Radiological Health

Office of In Vitro Diagnostics and Radiological

510(k) K123616

Indications for use

16

L745 Linear Array Transducer: 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)	P	P	P				Note 1	Note 2,3
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph.(non-Card)
		Musculo-skeletal
(Conventional)	P	P	P				Note 1	Note 2
		Musculo-skeletal
(Superficial)	P	P	P				Note 1	Note 2
		Intravascular
		Other (Urology)
		Other (Ob/GYN)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular(Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
		Other (specify)
		Peripheral
Vessel	Peripheral vessel	P	P	P				Note 1
			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.)

(Division Sign Off)

Division of Radiological Hea

Office of In Vitro Diagnostics and Radio

510(k) K123616

2-12

17

L746 Linear Array Transducer: 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)	P	P	P				Note 1	Note 2,3
	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)	P
P	P
P					Note 1
Note 1	Note 2
Note 2
Cardiac	Cardiac Adult
Cardiac Pediatric
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra-cardiac
Other (specify)
	Peripheral
Vessel	Peripheral vessel	P	P					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.)

(Division Sign Off)

Division of Radiological Heatth

Office of In Vitro Diagnostics and Radiological

Indications for use

-510(k) K123616