S12 Digital Color Doppler Ultrasound System

• K Number: K152396
• Device Name: S12 Digital Color Doppler Ultrasound System
• Manufacturer: SONOSCAPE MEDICAL CORP.
• Date Cleared: 2015-09-03 ( 10 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Special
• Panel: Radiology
• Reference & Predicate Devices: K142474
• Predicate For: K170078

Intended Use

The SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, 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 (specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Description

This SonoScape S12 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 basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The subject of this submission is the addition of new probes to the legally marketed SonoScape S12.

New probes Add 3C-A, 4P-A and 10l2 probes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SonoScape S12 Digital Color Doppler Ultrasound System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the SonoScape S12 Digital Color Doppler Ultrasound System does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages, sensitivity/specificity thresholds) or detailed reported device performance in terms of these metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (SonoScape S12 K142474) and compliance with relevant industry standards. The performance is assessed by confirming that the device meets its design specifications and conforms to applicable medical device standards, which implies satisfactory performance for its intended use.

Qualitative Acceptance Criteria (Implied by the 510(k) Summary):

Acceptance Criteria Category	Reported Device Performance (as stated in the summary)
Intended Use	The SonoScape S12 system has the same intended uses as the legally marketed SonoScape S12 (K142474).
	Evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. (Pages 3, 23)
Technical Characteristics	The basic and key technical features of the Subject Device S12 are the same as the legally marketed SonoScape S12 (K142474), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Power Supply, Operating and Storage Condition and Screen Size. (Page 23)
Probe Performance	Performance and clinical application of new probes (3C-A, 4P-A, 1012) are stated to be the same or similar and meet clinical use compared to existing predicate probes (C344, 2P1, L741 respectively). (Page 24)
Safety and Effectiveness	The device complies with the same regulation and safety standards and has consistent acoustic output levels as the predicate device. "No new risk is raised." (Page 25)
Compliance with Standards	The S12 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3. (Page 25)
Design Specifications	Laboratory tests (including Phantom tests) were conducted to verify that the S12 system met all design specifications. (Page 25)

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation. The submission relies on non-clinical tests (laboratory and phantom tests) to verify design specifications and compliance with standards.

The data provenance is implied to be from internal laboratory testing conducted by SonoScape Medical Corp. in China. The study is not a retrospective or prospective clinical study on patient data in the typical sense for demonstrating diagnostic accuracy or clinical effectiveness.

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

This information is not provided in the document as there was no clinical testing requiring expert review for ground truth establishment. The document refers to non-clinical laboratory and phantom tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the submission did not involve clinical testing or human reader studies requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No clinical testing was required." (Page 25). Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI assistance is not mentioned or evaluated in this context.

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

This aspect is not applicable as the SonoScape S12 is a diagnostic ultrasound system and does not appear to feature AI algorithms requiring standalone performance evaluation in this 510(k) submission. The document primarily focuses on hardware and core imaging modalities.

7. The Type of Ground Truth Used

For the non-clinical tests (laboratory and phantom tests), the "ground truth" would have been established by:

• Known physical properties of phantoms: For acoustic output, imaging resolution, penetration, etc., phantoms with well-defined characteristics serve as the ground truth.
• Engineering specifications and standards: Compliance with IEC and ISO standards dictates the expected performance and limits.
• Comparison to predicate device's established performance: The primary method for demonstrating safety and effectiveness is substantial equivalence to the predicate device (K142474), implying that the predicate's performance serves as an established baseline.

8. The Sample Size for the Training Set

This information is not applicable as the submission does not describe an AI or machine learning model that would require a "training set." The device is a traditional ultrasound imaging system.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a caduceus-like symbol in front of them.

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

September 3, 2015

SONOSCAPE MEDICAL CORP. % Ms. Toki Wu Regulatory Affairs Manager 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051, Guangdong CHINA

Re: K152396

Trade/Device Name: S12 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: August 20, 2015 Received: August 24, 2015

Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert Oals

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152396

Device Name

S12 Digital Color Doppler Ultrasound System

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The SonoScape S12 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, 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) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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SonoScape S12 System:

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

Intended Use: Diagnostic ultrasound imaqinq 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
	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6,7
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Fetal	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
Imaging&	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
Other	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: B/M; B/PWD; B/THl; 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 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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Transducer: C322 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
	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
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/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

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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
	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
FetalImaging&Other	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/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

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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 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	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
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THl; M/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

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Transducer: C542 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
	Fetal
	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 2,4
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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Transducer: 3C-A 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
	Fetal	E	E	E		E	E	Note 1	Notes 2,4
	Abdominal	E	E	E		E	E	Note 1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging&	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)	E	E	E		E	E	Note 1	Notes 2,4
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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Transducer: VC6-2 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*Combined	Other*Specify
General(TRACK 1ONLY)	Specific(TRACKS 1 & 3)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler
	Ophthalmic	Ophthalmic
		Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	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 2,4,5
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/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

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Transducer: C613 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
	Fetal
	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 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

{13}------------------------------------------------

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

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

{14}------------------------------------------------

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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6,7
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THl; M/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

{15}------------------------------------------------

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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THl; M/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

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

Transducer: 10L1 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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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

Transducer: 1012 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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	E	E	E		E	E	Note 1	Notes 2,4,6
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	E	E	E		E	E	Note 1	Notes 2,4
	Musculo-skeletal(Superficial)	E	E	E		E	E	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	E	E	E		E	E	Note 1	Notes 2,4
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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

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	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/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

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

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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

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

Transducer: BCC9-5 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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THl; M/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

{21}------------------------------------------------

Transducer: BCL10-5 Biplane 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
	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel
	Cerebral vascular

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

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/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

{22}------------------------------------------------

510(k) Summary

1. Submitter [21 CFR807.92 (a) (1)]

Submitter:	SONOSCAPE MEDICAL CORP.
Address:	4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road,
	Nanshan, Shenzhen 518051, Guangdong, China
Contact Person:	Toki Wu
Tel:	[phone]
Fax:	[phone]
Email:	[e-mail]
Date Prepared	August 20, 2015

2. Device [21 CFR807.92 (a) (2)]

Trade Name:	S12 Digital Color Doppler Ultrasound System
Common Name:	Diagnostic Ultrasound System and Transducers

Classification Regulatory:

	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

Classification Panel: Radiology Device Class: ll

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

The identified predicate device within this submission is as follows: SonoScape S12 Digital Color Doppler Ultrasound System K142474

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

This SonoScape S12 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 basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of

{23}------------------------------------------------

anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

The subject of this submission is the addition of new probes to the legally marketed SonoScape S12.

New probes Add 3C-A, 4P-A and 10l2 probes.

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

The SonoScape S12 system 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.

6. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

S12 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:

SonoScape S12 Digital Color Doppler Ultrasound System K142474

Intended Use Comparison:

Compared with the legally marketed SonoScape S12 (K142474), the Subject Device S12 has the same intended uses.

Technical Characteristics Comparison:

The basic and key technical features of the Subject Device S12 are the same as the legally marketed SonoScape S12 (K142474), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Power Supply, Operating and Storage Condition and Screen Size.

The detailed technical features can be found in General Device Descriptions of this submission.

{24}------------------------------------------------

Probes Comparison:

Subject device S12 has the similar probes as the legally marketed SonoScape S12 (K142474).

	Table 1 Probes Comparison
Subject deviceSonoScape S12	Predicate DeviceLegally marketedSonoScape S12 (K142474)	Remark
C322 Curved Array	C322 Curved Array
C344 Curved Array	C344 Curved Array
C354 Curved Array	C354 Curved Array	SEAnalysis1a)
C542 Curved Array	C542 Curved Array
3C-A Curved Array
VC6-2 Curved Array	VC6-2 Curved Array	Same
C613 Micro-curved Array	C613 Micro-curved Array	Same
2P1 Phased Array	2P1 Phased Array
5P1 Phased Array	5P1 Phased Array	SEAnalysis1b)
4P-A Phased Array
L741 Linear Array	L741 Linear Array
L742 Linear Array	L742 Linear Array	SEAnalysis1c)
10L1 Linear Array	10L1 Linear Array
1012 Linear Array
6V1 Micro-curved Array	6V1 Micro-curved Array
EC9-5 Micro-curved Array	EC9-5 Micro-curved Array
BCC9-5 Micro-convex Array	BCC9-5 Micro-convex Array	Same
BCL10-5 Micro-convex Array	BCL10-5 Micro-convex Array

	Table 1 Probes Comparison

SE Analysis 1:

Compared with the legally marketed SonoScape S12 (K142474), there are three additional probes for the subject device, which are 3C-A, 4P-A and 1012.

• a) The performance and clinical application of 3C-A probe are the same as C344; and though the frequency of them is slightly different, they both meet the clinical use.
• b) The performance of 4P-A probe is the same as 2P1; the clinical application of 4P-A probe is covered in that of 2P1; and though the frequency of them is slightly different, they both meet the clinical use.
• c) The frequency, performance and clinical application of 1012 probe are the same as L741.

Note: detailed description information about the new probes can be found in Substantial Equivalence Comparison.

{25}------------------------------------------------

Moreover, compared with predicated device, the subject device (S12) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

7. Non-Clinical Tests [21 CFR 807.92(b) (1)]

The S12 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

Laboratory tests (including Phantom tests) were conducted to verify that the S12 system met all design specifications and the S12 system conformed to applicable medical device standards.

The S12 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.

8. Clinical Test [21 CFR 807.92(b) (2)]

No clinical testing was required.

9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]

In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that S12 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.

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.