PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

• K Number: K130119
• Device Name: PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
• Manufacturer: SONOSCAPE COMPANY LIMITED
• Date Cleared: 2013-04-12 ( 86 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

Predicate Devices

K112602

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with various imaging modes and digital architecture. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies summary.

Therapeutic

No.
The device is described as an "ultrasonic imaging instrument" and a "diagnostic ultrasound system" intended for "evaluation" and "clinical diagnostic imaging applications," indicating its purpose is for diagnosis, not treatment.

Diagnostic

Yes
The "Device Description" explicitly states, "The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications." It also describes the system as 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 color ultrasound imaging system" and mentions "imaging transducers," 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.
• Device Function: The SonoScape S2 is an ultrasound imaging system. It uses sound 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 "ultrasonic imaging" and "evaluation" of various anatomical sites. This is consistent with diagnostic imaging, not in vitro testing.

Therefore, the SonoScape S2 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 SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN, Cardiac Adult, Cardiac Pediatric, Peripheral vessel. Some transducers were specified for certain applications.

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

IYN, IYO, ITX

Device Description

The SonoScape S2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn, Urology.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

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 S2 Portable Digital Color Doppler Ultrasound 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". Based on non-clinical test results, S2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.

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.

K112602

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

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

APR 1 2 2013

510(k) Submission

510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

December 30, 2012

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor:	SonoScape Company Limited
Address:	Yizhe Building, Yuquan Road, Nanshan, Shenzhen
518051, P.R.China
Contact Name:	Zhou Wenping
Telephone No.:	[phone]
Fax No. :	[phone]
Email Address:	[e-mail] / [e-mail]

3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

Trade Name:	S2 Portable Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers
Classification:
21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System		Product code: IYN
21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System		Product code: IYO
21 CFR892.1570 Diagnostic Ultrasonic Transducer		Product code: ITX
Classification Panel:	Radiology
Device Class:	II

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicates within this submission are as follows:

510(k) Summary of Safety and Effectiveness

1

K130119 Page 2 of 5

510(k) Submission

SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date – November 07, 2011).

5. Description of the Device [21 CFR 807.92(a)(4)]

The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

6. Intended Use [21 CFR 807.92(a)(5)]

The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

| No. | Probe | Type | Frequency
Range | Intended Use |
|-----|-------|-----------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1 | 2P1 | Phased Array | 2.0-4.0 MHz | Abdominal |
| | | | | Neonatal Cephalic |
| No. | Probe | Type | Frequency
Range | Intended Use |
| | | | | Adult Cephalic
Cardiac Adult
Cardiac Pediatric |
| 2 | 5P1 | Phased Array | 4.0-7.0 MHz | Pediatric
Neonatal Cephalic
Cardiac Pediatric |
| 3 | 6V1 | Micro-curved
Array | 4.0-8.0 MHz | Trans-rectal
Trans-vaginal |
| 4 | 6V3 | Micro-curved
Array | 5.0-9.0 MHz | Trans-rectal
Trans-vaginal |
| 5 | EC9-5 | Micro-curved
Array | 5.0-9.0 MHz | Trans-rectal
Trans-vaginal |
| 6 | C611 | Micro-curved
Array | 4.0-8.0 MHz | Abdominal
Pediatric
Neonatal Cephalic
Cardiac Pediatric |
| 7 | C344 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 8 | C362 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 9 | VC6-2 | curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 10 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)
Musculo-skeletal (Conventional)
Peripheral vessel |
| 11 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid,testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel |
| 12 | L743 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid,testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel |
| 13 | C354 | curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |

Table 1 Transducer Information

510(k) Summary of Safety and Effectiveness

2

K130119 Page 3 of 5

Portable Digital Color Doppler Ultrasound System

510(k) Submission

3

KB0119 Page 4 of 5
510(k) Submission

510(k) Submission

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

Safety Considerations:

The S2 Portable Digital Color Doppler Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 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 UID 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO10993-5and ISO 10993-10. Testing:

Laboratory testing was conducted to verify that the S2 Portable Digital Color Doppler Ultrasound 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	Medical Electrical Equipment - Part1.
General Requirements for Safety	1988+A1:
1991+A2:
1995	10/31/2005
IEC
60601-1-2	Medical Electrical Equipment, Part 1-2:
General Requirements for Safety –
Collateral Standard: Electromagnetic
Compatibility – Requirements and Tests	2007	03/01/2007
IEC	Medical Electrical Equipment, Part 2-37:	2007	08/01/2007

Tab 2 Applicable Safety Standards

510(k) Summary of Safety and Effectiveness

4

K130119 Page 5f5

510(k) Submission

Portable Digital Color Doppler Ultrasound System

| 60601-2-37 | Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and
Monitoring Equipment | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|------|------------------------|
| NEMA UD 2 | Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Version 3 | 2004 | 01/01/2004
(R 2009) |
| NEMA UD3 | Standard for Real-Time Display of Thermal
and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment | 2004 | 01/01/2004
(R 2009) |
| ISO 10993-5 | Biological evaluation of medical devices -
Part 5: Tests for In Vitro cytotoxicity | 1999 | 09/12/2007 |
| ISO
10993-10 | Biological evaluation of medical devices -
Part 10: Tests for irritation and delayed-type
hypersensitivity | 2002 | 09/01/2002 |

Results of performance and compliance testing conducted on the S2 Portable Digital Color Doppler Ultrasound System, indicates conformance to all applicable standards recognized by FDA for this device.

Based on non-clinical test results, $2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices in safety and effectiveness.

9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S2 Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

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

April 12, 2013

SonoScape Company Limited % Miss Toki Wu Official Correspondent Yizhe Building, Yuquan Road Nanshan, Shenzhen 518051 P.R. CHINA

Re: K130119

Trade/Device Name: S2 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 28, 2012 Received: February 20, 2013

Dear Miss Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 S2 Portable Digital Color Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1 Phase Array 5P1 Phase Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array

C344 Curved Array C354 Curved Array VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array

6

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number: K130119

Device Name: S2 Portable Digital Color Doppler Ultrasound System

Indications for Use:

The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

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 In Vitro Diagnostics and Radiological Health (OlR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119

8

System: SonoScape S2

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging 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	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative Specify.
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,5
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
Fetal
Imaging&
Other	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color

Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119

Indications for Use

Page 2 of 15

9

Transducer: 2P1 Phase 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	Specific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)
Doppler	Combined	Specify
ONLY)
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&
Other	Abdominal	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	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: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color

Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119

10

Transducer: 5P1 Phase 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	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
Vessel	Peripheral vessel
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

• Note 5: Small Organ: breast, thyroid, testes
  (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)

11

Transducer: 6V1 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	Specific					Color	Power	Other*	Other*
(TRACK 1	(TRACKS 1 & 3)	B	M	PWD	CWD	Doppler	(Amplitude)	Combined	Specify
ONLY)							Doppler
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&	Abdominal
Other	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	p		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral						t
	Trans-esoph (non-Card)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) ======================================================================================================================================================================= K130119

Indications for Use

Page 5 of 15

12

Transducer: 6V3 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	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) · Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _________K130119

13

Transducer: EC9-5 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	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130119

Indications for Use

Page 7 of 15

14

Transducer: C611 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	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	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: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

i 510(k)

15

Transducer: C362 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	Fetal	P	P	P		P	P	Note 1	Notes 2
Imaging &
Other	Abdominal	P	P	P		P	P	Note 1	Notes 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 (Ob/GYN)	P	P	P		P	P	Note 1	Notes 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: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color

Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

• Note 5: Small Organ: breast, thyroid, testes
  (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) == K130119

Indications for Use

Page 9 of 15

16

Transducer: C344 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	P	P	P		P	P	Note 1	Notes 2
	Abdominal	P	P	P		P	P	Note 1	Notes 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 (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
	Peripheral
Vessel	Peripheral vessel
Other (specify)

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130119

Indications for Use

Page 10 of 15

17

Transducer: C354 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	Fetal	N	N	N		N	N	Note 1	Notes 2
Imaging&	Abdominal	N	N	N		N	N	Note 1	Notes 2
Other	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 (Ob/GYN)	N	N	N		Z	N	Note 1	Notes 2
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

P = previously cleared by FDA; N = new indication; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119

Indications for Use

Page 11 of 15

18

Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic utrasound 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
Imaging &
Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	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 (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

P = previously cieared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 4: 4D Note 3: TDI

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130119 K130119 510(k) =======================================================================================================================================================================

Indications for Use

Page 12 of 15

19

Transducer: L743 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)	P	P	P		P	P	Note 1	Notes 2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________ K130119

20

Transducer: L741 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	CW
D	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card)
	Musculo-skeletal	P	P	P		P	P	Note 1	Notes 2
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
Vessel	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130119

Indications for Use

Page 14 of 15

21

Transducer: L742 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	Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal	P	P	P		P	P	Note 1	Notes 2
	(Conventional)
	Musculo-skeletal	P	P	P		P	P	Note 1	Notes 2
	(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
Vessel	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 4D

Note 5: Small Organ: breast, thyroid, testes

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130119 510(k)