The 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 SonoScape S6 Diagnostic 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, 3D/4D.

AI/ML Overview

This is a 510(k) premarket notification for the SonoScape S6 Diagnostic Ultrasound System. The document focuses on establishing substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving device performance against specific clinical endpoints. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for diagnostic tasks. Instead, it relies on demonstrating substantial equivalence to a predicate device by conforming to recognized safety and performance standards.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety Standards	IEC 60601-1 (1988), Amendment 1 (1991), Amendment 2 (1995)	Device conforms to this standard.
	IEC 60601-1-2 (Second Edition, 2001)	Device conforms to this standard.
	IEC 60601-2-37 (2004) (2005) Amendment 2	Device conforms to this standard.
	NEMA UD 2-2004	Acoustic output measured and calculated per NEMA UD 2: 2004 and NEMA UD3: 2004.
	ISO 10993-5:1999 (Biological evaluation - In Vitro cytotoxicity)	Device conforms to this standard (biocompatibility).
	ISO 10993-10:2002 (Biological evaluation - Irritation/hypersensitivity)	Device conforms to this standard (biocompatibility).
Functional Equivalence	Met all design specifications	Laboratory testing verified that the device met all design specifications and was substantially equivalent to the predicate device.
	Same fundamental technology as predicate device	The S6 Diagnostic Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device (S20 Digital Doppler Ultrasound System and Transducers - K110510).
Intended Use	(General purpose, multi-application)	Intended for use for 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.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The submission describes laboratory testing for engineering characteristics and adherence to standards, not a clinical trial with a "test set" of patients or data in the context of AI performance. The term "test set" as typically used for AI device evaluation is not relevant here.
Data Provenance: Not applicable. The testing described is primarily laboratory-based (acoustic output, electrical safety, biocompatibility) rather than on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. Ground truth, in the context of clinical diagnostic accuracy, is not discussed as this is a 510(k) for an ultrasound system, not an AI diagnostic algorithm. The evaluation focuses on engineering performance and safety.
Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is a 510(k) for a diagnostic ultrasound system itself, not an AI algorithm intended to assist human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. The device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. There is no "algorithm only" performance reported in the context of AI.

7. The Type of Ground Truth Used

Not applicable in the context of clinical diagnostic ground truth. The "truth" for the described testing relies on physical measurements against engineering specifications and adherence to established medical device safety and performance standards (e.g., acoustic output values, electrical impedance, biological reactivity in in-vitro tests).

8. The Sample Size for the Training Set

Not applicable. The document describes a traditional medical device (an ultrasound machine), not an AI/Machine Learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is not relevant to this submission.

Summary

{0}------------------------------------------------

K112602

NOV - 7 2011

Tab 21 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:

Manufacturer:

SonoScape Company Limited

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

Tel: (86) 755-26722890

Fax: (86) 755-26722850

Contact Person: Chen Zhiqiang

Date Prepared: August 31, 2011

Name of the device:

Trade/Proprietary Name:

S6 Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System and Transducers
Classification:

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Legally Marketed Predicate Device:

S20 Digital Doppler Ultrasound System and Transducers -K110510

Device Description:

The SonoScape S6 Diagnostic Ultrasound System is an integrated preprogrammed

{1}------------------------------------------------

SonoScape Company LTD

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, 3D/4D.

Intended Use:

{2}------------------------------------------------

Probe Information:

No.	Probe	Type	Frequency Range	Intended Use
1	2P1	Phased Array	2.0-4.0 MHz	AbdominalNeonatal CephalicAdult CephalicCardiac AdultCardiac Pediatric
2	5P1	Phased Array	3.0-7.0 MHz	PediatricNeonatal CephalicCardiac Pediatric
3	6V1	Micro-curvedArray	4.0-8.0 MHz	Trans-rectalTrans-vaginal
4	6V3	Micro-curvedArray	5.0-9.0 MHz	Trans-rectalTrans-vaginal
5	EC9-5	Micro-curvedArray	5.0-9.0 MHz	Trans-rectalTrans-vaginal
6	C611	Micro-curvedArray	4.0-8.0 MHz	AbdominalPediatricNeonatal CephalicCardiac 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

Tab 21.1 Probe information

Safety Considerations:

The S6 Diagnostic 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

Premarket Notification 510(k) Summary

{3}------------------------------------------------

NEMA UD 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 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10.

Testing:

Laboratory testing was conducted to verify that the S6 Diagnostic 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".

Tab 21.2 Applicable Safety Standards
--------------------------------------	--

Standards No.	Standards Title	Version	Date
IEC 60601-1	IEC 60601-1, Medical Electrical Equipment - Part 1:General Requirements for Safety, 1988; Amendment1, 1991-11, Amendment 2, 1995.	1988	10/31/2005
IEC 60601-1-2	IEC 60601-1-2, (Second Edition, 2001), MedicalElectrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility -- Requirements andTests.	2007	07/31/2008
IEC60601-2-37	IEC 60601-2-37 (2004) (2005) Amendment 2,Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment.	2007	09/08/2009
NEMA UD 2	NEMA UD 2-2004, Acoustic Output MeasurementStandard for Diagnostic Ultrasound EquipmentVersion 3.	2004	09/08/2009
ISO 10993-5	ISO 10993-5:1999, Biological evaluation of medicaldevices -- Part 5: Tests for In Vitro cytotoxicity.	2009	09/12/2007
ISO 10993-10	ISO 10993-10:2002, Biological evaluation of medicaldevices - Part 10: Tests for irritation and delayed-typehypersensitivity.	2002	09/12/2007

Premarket Notification 510(k) Summary

{4}------------------------------------------------

Conclusion:

The conclusions drawn from testing of the S6 Diagnostic Ultrasound System with transducer demonstrate that the device is as safe and effective as the legally marketed predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

NOV - 7 2011

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

Re: K112602

Trade/Device Name: S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 6, 2011 Received: September 7, 2011

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 S6 Diagnostic Ultrasound System, as described in your premarket notification: 1

Transducer Model Number

2P1 Phased Array 5P1 Phased Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array

{6}------------------------------------------------

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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 (301) 796-6242.

Sincerely Yours.

Mary Stott

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{7}------------------------------------------------

4.4 Tab 3 Indications For Use

510(k) Number:

Device Name:

S6 Diagnostic Ultrasound System

Indications for Use:

The SonoScape S6 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 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)

Mary S. Patil

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

510(k) Number K112602

Indications For Use

{8}------------------------------------------------

System: SonoScape S6 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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal	N	N	N		N	N	Note 1	Notes 2,4,5
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2,4,6
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	N	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	N	N	N		N	N	Note 1	Notes 2,4
	Intravascular
Cardiac	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4,5
	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)		ר
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2,4
	Other (specify)
N = new indication;P = previously cleared by FDA:E = added under this appendit

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: 3D

Note 6: Small Organ: breast, thyroid, testes

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

Note 5: 4D

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)

Indications For Use

Mary S. Patil
(Division Sign-Off)

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

510K K112602

{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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	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/TH; MC; 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: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Indications For Use

May S. Pisto
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Di tic Device Evaluation and Safety

K112602
510K

{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
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	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	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	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 Doppler; B/Color Doppler; W/C / P/aper Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TIDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

May Slatte
(Division Sign Off)

Office of Ir

510K K112602

{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(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal.	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	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)
PeripheralVessel	Peripheral vessel
	Other (specify)
N = new indication;P = previously cleared by FDA;F = added under this appendix

Note 1: Other Combined includes: BM proved in viri.
Note in Bernined includes: BMM; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler; B/Color Doppler; W/D; B/Pover appendi Doppler/PWD

Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D

Note 3: TDI Note 4: 31)

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

Mary S/Patel
(Division Sign Off)

(Division Sign-C Division of Radiological Dev Office of In gnostic Device Evaluation and Safety

510K K112602

{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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	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)
PeripheralVessel	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 Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

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

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

Mary S. Postel
(Divide Dir., OPS)

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

510K K112602

{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
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	Notes 2,4
	Trans-vaginal	N	N	N		N	N	Note 1	Notes 2,4
	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)
PeripheralVessel	Peripheral vessel
	Other (specify)

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: BM; B/W/D; B/TH| M/Color Doppler: B/Color Doppler: B/Color Dopper/PWD; B/Power Doppler/PWD

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

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 41)

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

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

EICH

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

Indications For Use

Mary Potts

(Division Sign-Off)

Division of Radiological Devic Office of In fitro Diagnostic Device Evaluat on and Safety

{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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletai(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

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

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

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Indications For Use

Mary S. Petty
(Division Sign Off)

(Division Sign-Off) Division of Radiological Devic Office of In tro Diagnostic Device Evaluation and Safety

510K K112602

{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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	N	N	N		N	N	Note 1	Notes 2,4
	Abdominal	N	N	N		N	N	Note1	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)	N	N	N		N	N	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)
N = new indication;						P = previously cleared by FDA:		E = added under this appendix

P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/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: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Indications For Use

Mary S. Lath
(Division Sign-Off)

Division of Radiologic Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112602

{16}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal	N	N	N		N	N	Note 1	Notes 2, 4
	Abdominal	N	N	N		N	N	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-skeleta!(Superficial)
	Intravascular
Cardiac	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2, 4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Other (specify)

P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: BM: B/WD; B/THT; MC: 0/Color Doppler; B/Color Doppler; B/Color Dopper/FW V); B/Pover Doppler/PWD

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

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

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)

Indications For Use

Mury S. Pett

Division of Radiological Devices Office of In Vitro Diag Evaluation and Safety

610K K112602

{17}------------------------------------------------

SonoScape Company LTD

Diagnostic Ultrasound Indications for Use Form

Transducer: VC6-2 Curved Array Diagnostic Ultrasound Transduccr

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

Clinical Application		Mode of Operation
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	N	N	N		N	N	Note 1	Notes 2,4,5
	Abdominal	N	N	N		N	N	Note 1	Notes 2,4,5
	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
Cardiac	Other (Ob/GYN)	N	N	N		N	N	Note 1	Notes 2,4,5
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	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/TH!; M/Color Doppler; B/Color Doppler B/Color Doppled WWer ansaper Doppler/PWD

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

Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

Note 3: TDI

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)

Indications For Use

Mary Spat
(Division Sign Off)

Division of Radiological Devices Office of In ce Evaluation and Safety

510K K112602

{18}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	N	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)	N	N	N		N	N	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2, 4
	Other (specify)

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

Note 5: 4D -

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

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

Mary Patel

(Division Sign-Off)

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

510K: K112602

{19}------------------------------------------------

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	N	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2, 4
	Other (specify)

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

Note 5: 4D

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

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

Mary Shitol
(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagno and Safety

510K K112602

{20}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	Other*Specify
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	N	N	N		N	N	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	N	N	N		N	N	Note 1	Notes 2, 4
	Musculo-skeletal(Superficial)	N	N	N		N	N	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	Note 1	Notes 2, 4
	Other (specify)
N = new indication:P = previously cleared by FDA:E - oddad under this openedix

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH; M/Color Doppler; B/Color Doppler; B/Color Doppler/WD; B/Pover Doppler/PWD

Note 5: 4D

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

Note 3: T`DI Notc 4: 3D

Note 6: Small Organ: breast, thyroid, testes

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)

Indications For Use

May S. Patel
(Division Sign-Off)

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

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.