The SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound 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, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology.

Device Description

This SonoScape X3 Exp/X3/X3 Pro/X1 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a portable, 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, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Sonoscape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through a study with predefined metrics.

Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.

The document states:

"No clinical testing was required." This explicitly indicates that a clinical study designed to test performance against acceptance criteria was not part of this submission for substantial equivalence.
The tests conducted were non-clinical, primarily focused on safety and essential performance in comparison to recognized standards and the predicate device.

However, I can provide the following based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to a predicate device by asserting that the subject device has the "same technical characteristics" and "complies with the same regulation and safety standards."

Acceptance Criteria (Not explicitly stated as performance metrics, but implied from substantial equivalence)	Reported Device Performance
Same Intended Use as Predicate Device (SonoScape X5 K160258)	The Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same intended use as the predicate device. The intended use is "for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), OB/Gyn and Urology."
Same Technical Characteristics as Predicate Device	The Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same technical characteristics, "including Design, Operation Controls, Operation Mode, Display Modes, Measurement Items, Power Supply, Screen Size, Cine Loop, Operating and Storage Condition." Minimal hardware optimizations (video conversion chip, IO docking station isolation) are noted but stated "will not affect the safety and effectiveness."
Same Probes as Predicate Device	The Subject device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same probes as the predicate device SonoScape X5 (K160258), including: 3C-A Curved Array, C613 Micro-curved Array, 3P-A Phased Array, 7P-B Phased Array, L741 Linear Array, 6V1 Micro-curved Array, EC9-5 Micro-curved Array, PWD2.0 TCD.
Compliance with Safety Standards	The system was evaluated for "electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output" and designed/manufactured to meet standards including: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, AIUM/NEMA UD 2:2004 (R2009), and AIUM/NEMA UD 3:2004 (R2009). The acoustic output levels are stated to be "consistent."
Substantial Equivalence	Based on the above comparisons, the device is concluded to be "substantially equivalent" to the predicate device in safety and effectiveness, implying it meets the same implicit performance levels as the predicate and raises no new safety or effectiveness concerns. This means its performance is assumed to be acceptable because it is similar to a device already cleared by the FDA, not quantified by new objective data or specific performance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission states "No clinical testing was required." The "phantom tests" mentioned under Non-Clinical Tests would involve phantoms, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set with expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool, and no MRMC study was mentioned or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is an ultrasound system, not an algorithm being evaluated in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical "phantom tests," the ground truth would be based on the known, controlled properties of the phantoms used. No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set. The device's "development" would involve engineering design and validation against specifications, not machine learning training.

9. How the ground truth for the training set was established

This information is not applicable. As explained above, this is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

January 3, 2017

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, GuangDong 518051 CHINA

Re: K163427

Trade/Device Name: X3 Exp/X3/X3 Pro/X1 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: November 30, 2016 Received: December 6, 2016

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

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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. 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 (800) 638 2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Michael D'Hara

For

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)

K163427

Device Name

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SonoScape X3 Exp/X3/X3 Pro/X1 Pro/X1 System:

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	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	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,6
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
FetalImaging&Other	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	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
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2
	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular			P

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

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: 3C-A Curved Array

Diagnostic Ultrasound Transducer

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

Clinical ApplicationGeneral(TRACK 1ONLY)	Mode of Operation
	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
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	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
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	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 2: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Note 7: Elastography

Note 5: 4D

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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 ApplicationMode 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	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
	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	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2
	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/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: 3P-A Phased 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
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
FetalImaging&Other	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Trans-rectal
	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
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2
Cardiac	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 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: 7P-B Phased 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 Power Other* Specific Color Other* (TRACK 1 (Amplitude) Specify (TRACKS 1 & 3) B PWD CWD M Doppler Combined ONLY) Doppler Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Specify Intra-operative Neuro Laparoscopic Pediatric Notes 2 P P P P P Note 1 Small Organ (specify) Neonatal Cephalic P P P P P P Note 1 Notes 2 Adult Cephalic Fetal Trans-rectal Imaging& Trans-vaginal Other 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 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: 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: 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 2,6
	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
	Musculo-skeletal(Superficial)	P	P	P		P	P	Note 1	Notes 2
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Cerebral vascular
	PeripheralVessel

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: 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
	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
	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)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2
	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
Cardiac	Intra-cardiac
	Other (specify)
	Peripheral vessel
	Cerebral vascular
PeripheralVessel

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: 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
Fetal	Adult Cephalic
Imaging&	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
Other	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)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular(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: PWD2.0

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
Fetal	Adult Cephalic			P
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
	Cardiac Pediatric
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Cerebral vascular			P

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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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:	+86 755 26722890
Fax:	+86 755 26722850
Email:	ra@sonoscape.net
Date Prepared	December 23, 2016

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

Trade Name:	X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler UltrasoundSystem
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 X5 Digital Color Doppler Ultrasound System

K160258

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

The X3 Exp/X3/X3 Pro/X1 Pro/X1 system utilizes the ultrasound echo characteristics,

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transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.

This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.

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

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

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:

SonoScape X5 Digital Color Doppler Ultrasound System K160258

Intended Use Comparison:

Compared with the predicate device SonoScape X5 (K160258), the Subject Device X3

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Exp/X3/X3 Pro/X1 Pro/X1 has the same intended use.

Technical Characteristics Comparison:

Compared with the predicate device SonoScape X5 (K160258), the Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same technical characteristics, including Design, Operation Controls, Operation Mode, Display Modes, Measurement Items, Power Supply, Screen Size, Cine Loop, Operating and Storage Condition.

Compared with the predicate device SonoScape X5 (K160258), there are some hardware optimizations made to the Subject Device X3 Exp/X3/X3 Pro/X1, including the modification of the video conversion chip in the display module which makes the display better, additional isolation to the IO docking station and other minor changes or optimizations on the circuit, which will not affect the safety and effectiveness of the Subject Device.

Probes Comparison:

Subject device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same probes as the predicate device SonoScape X5 (K160258).

Subject deviceSonoScape X5	Predicate DeviceSonoScape X5 (K160258)	Remark
3C-A Curved Array	3C-A Curved Array	Same
C613 Micro-curved Array	C613 Micro-curved Array
3P-A Phased Array	3P-A Phased Array
7P-B Phased Array	7P-B Phased Array
L741 Linear Array	L741 Linear Array
6V1 Micro-curved Array	6V1 Micro-curved Array
EC9-5 Micro-curved Array	EC9-5 Micro-curved Array
PWD2.0 TCD	PWD2.0 TCD

Table 1 Probes Comparison

And, compared with predicate device, the subject device (X3 Exp/X3/X3 Pro/X1 Pro/X1) 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.

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

The X3 Exp/X3/X3 Pro/X1 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 system met all design specifications and the X3 Exp/X3/X3 Pro/X1 Pro/X1 system conformed to applicable medical device standards.

The X3 Exp/X3/X3 Pro/X1 Pro/X1 system has been designed and manufactured to meet the following standards:

IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General

requirements for basic safety and essential performance [08/20/2012], including the US National Differences;

IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests [03/30/2007];

IEC 60601-2-37:2007, Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [08/09/2007];

ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity [06/01/2009];

ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization [08/01/2010];

AIUM/NEMA UD 2:2004 (R2009), Acoustic output measurement standard for diagnostic ultrasound equipment [08/21/2009]; and

AIUM/NEMA UD 3:2004 (R2009), Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment [08/13/2010].

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 X3 Exp/X3/X3 Pro/X1 Pro/X1 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.