S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

• K Number: K201059
• Device Name: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
• Manufacturer: Sonoscape Medical Corp.
• Date Cleared: 2020-07-30 ( 100 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K172607 , K173058 , K172082
• Predicate For: K222596

Intended Use

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic 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 (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

Device Description

This SonoScape S60 Elite Series 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. This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.

AI/ML Overview

The medical device in question is the Sonoscape S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059).

Based on the provided document, here's the information regarding its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Standard/Test Name	Device Performance (Result)	Details / Remarks
Electrical Safety	IEC 60601-1:2005+A1:2012	Passed	Met General requirements for basic safety and essential performance.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014	Passed	Met requirements for electromagnetic disturbances.
Acoustic Safety	IEC 60601-2-37:2015	Passed	Met particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Acoustic Output Limits: Derated ISPTA: 720mW/cm2 maximum, TIS/TIB/TIC: 6.0 maximum, MI: 1.9 maximum for all listed probes (3C-A, C1-6A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 10I2, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7).
	AIUM/NEMA UD 2:2004 (R2009)	Passed	Met acoustic output measurement standard for diagnostic ultrasound equipment.
Biocompatibility	ISO 10993-5:2009	Conformed	Met tests for in vitro cytotoxicity.
	ISO 10993-10:2010	Conformed	Met tests for irritation and skin sensitization.
Software Verification and Validation	IEC 62304:2006 +A1:2015	Passed
Functional Equivalence to Predicate Device	Comparison to SonoScape S60 Series (K172082) & Philips EPIQ 5/7 (K172607) & SonoScape P10 Series (K173058)	Substantially Equivalent	Demonstrated similar intended uses, compliance with regulations, consistent acoustic output, and similar probes and technical characteristics. Differences in frequency, operation modes (DPDI vs PDI), and functions are deemed not to raise new risks according to the SE Analyses (5, 6, 7).

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

• The document states that non-clinical tests (electrical safety, EMC, acoustic, biocompatibility, software verification/validation) were performed.
• No clinical testing was required for this 510(k) submission.
• Therefore, there is no specific "test set" in terms of patient data for an AI algorithm as typically understood in such studies. The evaluation focused on engineering and performance parameters against established standards.
• Data provenance: Not applicable as no clinical data test set was used.

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

• Not applicable. Since no clinical test set was utilized and no AI algorithm with independent ground truth establishment was conducted, there were no experts needed to establish ground truth for a clinical test set. The device is an ultrasound system, not an AI diagnostic tool requiring clinical ground truth for performance evaluation in this submission.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or subjective interpretations requiring adjudication were part of this 510(k) submission.

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:

• No. An MRMC comparative effectiveness study was not performed. This submission is for a general-purpose ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader performance with and without AI.

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

• No. This is not an AI algorithm. It is a digital color Doppler ultrasound system. The evaluation was of the system's compliance with safety and performance standards.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was based on the requirements and methodologies outlined in the specified international medical device standards (IEC, ISO, AIUM/NEMA). These standards define objective parameters and testing procedures for assessing the safety and performance of ultrasound systems.

8. The Sample Size for the Training Set:

• Not applicable. This submission does not pertain to an AI algorithm that requires a training set.

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

• Not applicable. As there is no AI algorithm training set, no ground truth needed to be established for it.

Summary

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July 30, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sonoscape Medical Corp. % Toki Wu Regulatory Affairs Manager Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Rd, Yuehai Subdistrict, Nanshan District Shenzhen, Guangdong 518057 CHINA

Re: K201059

Trade/Device Name: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2020 Received: July 6, 2020

Dear Toki 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201059

Device Name

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic 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 (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K201059

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

Submitter:	SONOSCAPE MEDICAL CORP.
Address:	Room 201 & 202, 12th Building, Shenzhen Software Park Phase II,1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,Shenzhen, 518057, Guangdong, China
Contact Person:	Toki Wu

Fax:	[phone]
------	------------------

Email: [e-mail]

Date Prepared July 2, 2020

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

Trade Name:	S60 Elite Series/S70 Series Digital Color Doppler UltrasoundSystem
Models:	S60 Expert, S60 Classic, S60 Nov, S60 Super, S60 Speci, S60Elite, S-Light, S70 Exp, S70, S70 Pro, S70S, S70 VO, S60S, S60N
Common Name:	Diagnostic Ultrasound System and Transducers

Classification Regulatory:

		CFR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System		892.1550	90-IYN
(Primary)
Ultrasonic Pulsed Echo Imaging System		892.1560	90-IYO
Diagnostic Ultrasound Transducer		892.1570	90-ITX
Classification Panel:	Radiology
Device Class:	II

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

The identified predicate device within this submission is as follows:

Type	Manufacturer	Device	510 (K) Number
Primary Predicate	SonoScape	S60 Series Digital Color	K172082
Device	Medical Corp.	Doppler Ultrasound System
Reference	Philips	EPIQ 5/EPIQ 7 Diagnostic	K172607

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Devices	Ultrasound, Inc.	Ultrasound System
Reference	SonoScape	P10 Series Digital Color K173058
Devices	Medical Corp.	Doppler Ultrasound System

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

This SonoScape S60 Elite Series 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.

This system consists of a mobile console with touch screen and 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, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.

Note 1: The S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is considered as two serial products of S60 Elite Series (including S60 Expert, S60 Classic, S60 Nov, S60 Speci, S60 Speci, S60 Elite, S-Light models) and S70 Series (including S70 Exp, S70, S70 Pro, S70S, S70 VO, S60S, S60N models), but they are the same except partial functions, including the same indications for use, configuration probe, design, hardware, software, mechanic construction, power supply board, main board, specification and etc.

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

5.1 Intended use

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal,

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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), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

5.2 Indications for use

The 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), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

The Modes of Operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.

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

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:

Type	Manufacturer	Device	510 (K) Number
Primary Predicate Device	SonoScape Medical Corp.	S60 Series Digital Color Doppler Ultrasound System	K172082
Reference Devices	Philips Ultrasound, Inc.	EPIQ 5/EPIQ 7 Diagnostic Ultrasound System	K172607
Reference Devices	SonoScape Medical Corp.	P10 Series Digital Color Doppler Ultrasound System	K173058

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System has the same intended uses, complies with the same regulation and safety standards, has the consistent acoustic output levels, has similar probes and has the same technical characteristics as the predicate device legally marketed S60 Series (K172082).

Intended Use Comparison:

Compared with the predicate device S60 Series (K172082), the Subject Device S60 Elite Series/S70 Series has the same intended use.

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Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60 Super/S60Speci/S60 Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Primary Predicate DeviceLegally marketedSonoScape S60 Exp/S60/S60Pro/S60 VO/S60 Maso/S59(K172082)	Remark
The Digital Color Doppler Ultrasound 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), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.	The 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), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.	Same

Table 2 Intended use Comparison

Technical Characteristics Comparison:

Compared with the predicate device S60 Series (K172082), the Subject Device S60 Elite Series/S70 Series has the similar technical characteristics, including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition. And the differences will not raise new risk and different questions of safety and effectiveness.

Probes Comparison:

Subject device S60 Elite Series/S70 Series has the similar probes as the predicate device SonoScape S60 Series (K172082).

Table 3 a) Probes Comparison

Subject Device	Primary Predicate Device	Remark
SonoScape S60 Expert/S60	Legally marketed

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Classic/S60 Nov/S60 Super/S60	SonoScape S60 Exp/S60/S60
Speci/S60 Elite/S-Light/S70 Exp/	Pro/S60 VO/S60 Maso/S59
S70/S70 Pro/S70S/S70	(K172082)
VO/S60S/S60N
C322 Micro-curved Array	C322 Micro-curved Array
3C-A Curved Array	3C-A Curved Array
C1-6 Curved Array	C1-6 Curved Array
C1-6A Curved Array	C1-6A Curved Array
6CT-A Curved Array	6CT-A Curved Array	SE
6CI-A Curved Array	6CI-A Curved Array	Analysis 1
C2-9 Curved Array	C2-9 Curved Array
C613 Micro-curved Array	C613 Micro-curved Array
VC2-9 Curved Array	VC2-9A Curved Array
VC6-2 Micro-curved Array	VC2-9 Curved Array
6V1 Micro-curved Array	6V3 Micro-curved Array
6V3 Micro-curved Array	6V3A Micro-curved Array
6V3A Micro-curved Array	6V7 Micro-curved Array
6V7 Micro-curved Array	BCC9-5 Micro-curved Array
BCC9-5 Micro-curved Array	BCL10-5 Biplane (Micro-curved +	SE
BCL10-5 Biplane (Micro-curved +Linear Array)	Linear Array)	Analysis 1
VE9-5 Micro-curved Array	VE9-5 Micro-curved Array
C3-10V Micro-curved Array	12C-ER Micro-curved Array
	C3-10V Micro-curved Array
8P1 Phased Array
4P-A Phased Array	8P1 Phased Array
S1-5 Phased Array	4P-A Phased Array	SE
7P-A Phased Array	S1-5 Phased Array	Analysis 2
3P-A Phased Array	7P-A Phased Array
7P-B Phased Array
1012 Linear Array	1012 Linear Array
9L-A Linear Array	9L-A Linear Array
12L-A Linear Array	12L-A Linear Array	SE
12L-B Linear Array	VL12-5 Linear Array	Analysis 3
13L-A Linear Array	12L-B Linear Array
18L-A Linear Array	13L-A Linear Array	SEAnalysis 4
12LT-A Linear Array	18L-A Linear Array
12LI-A Linear Array	ML3-18 Linear Array
L742 Linear Array	12LT-A Linear Array
L741 Linear Array	12LI-A Linear Array
L3-9 Linear Array
CWD2.0 CW	PWD2.0 Doppler
MPTEE Phased Array	CWD5.0 CW
MPTEE mini Phased Array	MPTEE Phased Array
LAP7 Linear Array	MPTEE mini Phased Array
	LAP7 Linear Array

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510(k) Submission

SE Analysis 1:

Compared with the predicate device, there are two new Micro-curved Array probes as followed: VC6-2, which is similar with the probe VC2-9 cleared with predicate device SonoScape S60 Series (K172082); and 6V1, which is similar with the probe 6V3 cleared with predicate device SonoScape S60 Series (K172082). All of these new transducers have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.

SE Analysis 2:

Compared with the predicate device, there are two new Phased Array probes as followed: 3P-A, which is similar with the probe 4P-A cleared with predicate device SonoScape S60 Series (K172082). The new probe 7P-B which is similar with the probe 7P-A cleared with predicate device SonoScape S60 Series (K172082). All of these new transducers have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.

SE Analysis 3:

Compared with the predicate device, there are two new Linear Array probes as followed: L742 and L3-9, which is similar with the probe 9L-A cleared with predicate device SonoScape S60 Series (K172082). The new transducers L742 have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP., and L3-9 is also legally marketed in S60 Series Digital Color Doppler Ultrasound System (K172082) and other series, manufactured by SONOSCAPE MEDICAL CORP.

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SE Analysis 4:

Compared with the predicate device, there is a new CW probes as followed: CWD2.0, which is similar with the probe CWD5.0 cleared with predicate device SonoScape S60 Series (K172082). The new transducers CWD2.0 have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.

Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

Functional Comparison of probes

Compared with the predicate device SonoScape S60 Series (K172082), there is new function of contrast imaging in probes (3C-A, C1-6A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 10I2, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7), which is similar with the probes (C6-2, L12-5, S5-1, C10-3v and C10-4ec) cleared with reference device EPIQ 5/EPIQ 7 Diagnostic Ultrasound System (K172607). The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use.

The engineering drawings of the new function transducers(probes) (3C-A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 1012, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7), and the further comparison are provided as followed.

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 1	3C-A	C6-2	/
Photo	Image: 3C-A	Image: C6-2	/

Table 3 b) Further Comparison for 3C-A Probe

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510(k) Submission

ProbeType	Curved Array	Curved Array	Same
Frequency	1.0-7.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal,Other(Ob/GYN),Abdominal,	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	CompoundImaging,ContrastImaging,Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4DImaging,XRES, Elastography	SEAnalysis 7

Table 3 c) Further Comparison for C1-6A Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Primary Predicate DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 2	C1-6A	C6-2	/
Photo	Image: C1-6A Probe	Image: C6-2 Probe	/
ProbeType	Curved Array	Curved Array	Same
Frequency	1.0-8.0MHz	2.0-6.0MHz	SEAnalysis 5

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510(k) Submission

Indicationfor use	Fetal,Other(Ob/GYN)	Abdominal,	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI, PW	B,THI,M,CFM,PDI,PW		SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum		Same
Functions	Compound Imaging,ContrastElastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography		SEAnalysis 7

Table 3 d) Further Comparison for C1-6 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 3	C1-6	C6-2	/
Photo	Image: SonoScape S60 Expert/S60 Probe	Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe	/
ProbeType	Curved Array	Curved Array	Same
Frequency	1.0-8.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal, Abdominal, Other(Ob/GYN)	General purpose abdominal (adult and pediatric, including vascular), bowel, obstetrical, gynecological, prostate and	Same

{12}------------------------------------------------

510(k) Submission

		interventional applications
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging,Contrast Imaging,Elastography	Compound Imaging,CPA,harmonic Imaging, Contrast Imaging,3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 e) Further Comparison for C2-9 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 4	C2-9	C6-2	/
Photo	Image: Ultrasound probe C2-9	Image: Ultrasound probe C6-2	/
ProbeType	Curved Array	Curved Array	Same
Frequency	2.0-13.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal, Abdominal,Other(Ob/GYN)	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6

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

510(k) Submission

AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging,Contrast Imaging	Compound Imaging, CPA,harmonic Imaging, Contrast Imaging,3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 f) Further Comparison for C322 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 5	C322	C6-2	/
Photo	Image: SonoScape S60 Expert/S60 Probe	Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe	/
ProbeType	Micro-curved Array	Curved Array	Same
Frequency	2.0-7.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal,Abdominal,Other(Ob/GYN)	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same

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

Functions	Compound Imaging, Contrast Imaging	Compound Imaging, CPA,THI, harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SE Analysis 7
-----------	------------------------------------	------------------------------------------------------------------------------------------------------------	----------------------

Table 3 g) Further Comparison for 6CT-A Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 6	6CT-A	C6-2	/
Photo	Image: 6CT-A Probe	Image: C6-2 Probe	/
ProbeType	Curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal,Abdominal,Other(Ob/GYN)	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging,THI,Contrast Imaging	Compound Imaging,CPA,harmonic Imaging,ContrastImaging,3D/4DImaging,	SEAnalysis 7

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

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 7	6CI-A	C6-2	/
Photo	Image: SonoScape S60 Expert/S60 Probe	Image: EPIQ 5/EPIQ 7 Diagnostic Probe	/
ProbeType	Curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	2.0-6.0MHz	SEAnalysis 5
Indicationfor use	Fetal, Abdominal,Other(Ob/GYN)	General purpose abdominal(adult and pediatric, includingvascular), bowel, obstetrical,gynecological, prostate andinterventional applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, THI,Contrast Imaging	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 h) Further Comparison for 6CI-A Probe

Table 3 i) Further Comparison for 12L-A Probe

Comparis	Subject Device	Reference Device	Remark
----------	----------------	------------------	--------

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

on Items	SonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Legally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)
Probe 8	12L-A	L12-5 50	/
Photo	Image: 12L-A	Image: L12-5 50	/
ProbeType	Linear Array	Linear Array	Same
Frequency	3.0-17.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid, testes), Musculo-skeletal(Conventional & Superficial), Peripheral vessel	Breast, thyroid and superficial small parts; musculoskeletaltendon, abdomen bowel, and vascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2 maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2 maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 j) Further Comparison for 12L-B Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
----------------------	--------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------	--------

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

510(k) Submission

	VO/S60S/S60N
Probe 9	12L-B	L12-5 50	/
Photo	Image: 12L-B probe	Image: L12-5 50 probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	3.0-17.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes), Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 k) Further Comparison for 9L-A Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 10	9L-A	L12-5 50	/
Photo	Image: 9L-A probe	Image: L12-5 50 probe	/

510(k) Summary

page 15 of 29

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

510(k) Submission

ProbeType	Linear Array	Linear Array	Same
Frequency	2.0-13.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes), Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging,3D/4DImaging,XRES, Elastography	SEAnalysis 7

Table 3 I) Further Comparison for L3-9 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 11	L3-9	L12-5 50	/
Photo	Image: Ultrasound probe	Image: Ultrasound probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	2.0-13.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes),Musculo-skeletal(Conventional & Superficial),	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, and	Same

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

	Peripheral vessel	vascular applications
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 m) Further Comparison for L741 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 12	L741	L12-5 50	/
Photo	Image: Ultrasound probe L741	Image: Ultrasound probe L12-5 50	/
ProbeType	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes),Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same

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

Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7
-----------	-----------------------------------------------------	-------------------------------------------------------------------------------------------------------	------------------

Table 3 n) Further Comparison for L742 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 13	L742	L12-5 50	/
Photo	Image: Ultrasound probe	Image: Ultrasound probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes), Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES, Elastography	SEAnalysis 7

Table 3 o) Further Comparison for 10I2 Probe

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

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 14	1012	L12-5 50	/
Photo	Image: SonoScape S60 Expert/S60 Probe	Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid, testes), Musculo-skeletal (Conventional & Superficial), Peripheral vessel	Breast, thyroid and superficial small parts; musculoskeletal tendon, abdomen bowel, and vascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES Elastography	SEAnalysis 7

Table 3 p) Further Comparison for 12LT-A Probe

Comparison Items	Subject Device	Reference Device	Remark
SonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/	Legally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)

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

510(k) Submission

	S70/S70 Pro/S70S/S70VO/S60S/S60N
Probe 15	12LT-A	L12-5 50	/
Photo	Image: 12LT-A Probe	Image: L12-5 50 Probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes),Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES, Elastography	SEAnalysis 7

Table 3 q) Further Comparison for 12Ll-A Probe

Comparison Items	Subject Device	Reference Device	Remark
	SonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Legally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)
	Probe 16	12LI-A	L12-5 50	/

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

510(k) Submission

Photo	Image: Ultrasound probe	Image: Ultrasound probe	/
ProbeType	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SEAnalysis 5
Indicationfor use	Small Organ (breast, thyroid,testes), Musculo-skeletal(Conventional & Superficial),Peripheral vessel	Breast, thyroid and superficialsmall parts; musculoskeletaltendon, abdomen bowel, andvascular applications	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging,CPA,harmonic Imaging,ContrastImaging,3D/4DImaging,XRES, Elastography	SEAnalysis 7

Table 3 r) Further Comparison for 4P-A Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 17	4P-A	S5-1	/
Photo	Image: 4P-A Probe	Image: S5-1 Probe	/
ProbeType	Phased Array	Phased Array	Same

510(k) Summary

page 21 of 29

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

510(k) Submission

Frequency	1.0-6.0MHz	1.0-5.0MHz	SEAnalysis 5
Indicationfor use	Abdominal, Cephalic, Cardiac	Abdominal, Cephalic, Cardiac	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES	SEAnalysis 7

Table 3 s) Further Comparison for 3P-A Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 18	3P-A	S5-1	/
Photo	Image: 3P-A probe	Image: S5-1 probe	/
ProbeType	Phased Array	Phased Array	Same
Frequency	1.0-6.0MHz	1.0-5.0MHz	SEAnalysis 5
Indicationfor use	Abdominal, Cephalic, Cardiac	Abdominal, Cephalic, Cardiac	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximum	Same

510(k) Summary

page 22 of 29

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

	MI: 1.9 maximum	MI: 1.9 maximum
Functions	Compound Imaging, Contrast Imaging	Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES	SEAnalysis 7

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 19	S1-5	S5-1	/
Photo	Image: SonoScape S60 Expert/S60 S1-5	Image: EPIQ 5/EPIQ 7 Diagnostic S5-1	/
ProbeType	Phased Array	Phased Array	Same
Frequency	1.0-7.0MHz	1.0-5.0MHz	SEAnalysis 5
Indicationfor use	Abdominal, Cephalic, Cardiac	Abdominal, Cephalic, Cardiac	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging, CPA,harmonic Imaging,ContrastImaging, 3D/4DImaging,XRES	SEAnalysis 7

Table 3 t) Further Comparison for S1-5 Probe

Table 3 u) Further Comparison for VE9-5 Probe

{26}------------------------------------------------

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 20	VE9-5	C10-3v	/
Photo	Image: VE9-5	Image: C10-3v	/
ProbeType	Micro-curved Array	Curved Array	Same
Frequency	2.0-13.0MHz	3.0-10.0MHz	SEAnalysis 5
Indicationfor use	Trans-vaginal	Fetal/OB,Trans-vaginal,Other: GYN/Urology	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, 3D/4D	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES	SEAnalysis 7

Table 3 v) Further Comparison for 6V1 Probe

Comparison Items	Subject Device	Reference Device	Remark
	SonoScape S60 Expert/S60	Legally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)
	Classic/S60 Nov/S60		Remark
	Super/S60 Speci/S60
	Elite/S-Light/S70 Exp/

{27}------------------------------------------------

510(k) Submission

	S70/S70 Pro/S70S/S70VO/S60S/S60N
Probe 21	6V1	C10-4ec	/
Photo	Image: 6V1 Probe	Image: C10-4ec Probe	/
ProbeType	Micro-curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	3.0-10.0MHz	SEAnalysis 5
Indicationfor use	Trans-rectal, Trans-vaginal	Fetal/OB,Trans-rectal,Trans-vaginal,Peripheralvessel, Other: GYN/Urology	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging	Compound Imaging,CPA,harmonic Imaging,ContrastImaging,3D/4DImaging,XRES	SEAnalysis 7

Table 3 w) Further Comparison for 6V3 Probe

	Subject Device	Reference Device
Comparison Items	SonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Legally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
	Probe 22	6V3	C10-4ec	/

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Photo
ProbeType	Micro-curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	3.0-10.0MHz	SEAnalysis 5
Indicationfor use	Trans-rectal, Trans-vaginal	Fetal/OB,Trans-rectal,Trans-vaginal,Peripheralvessel, Other: GYN/Urology	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging, CPA,harmonic Imaging, ContrastImaging, 3D/4D Imaging,XRES	SEAnalysis 7

Table 3 x) Further Comparison for 6V7 Probe

Comparison Items	Subject DeviceSonoScape S60 Expert/S60Classic/S60 Nov/S60Super/S60 Speci/S60Elite/S-Light/S70 Exp/S70/S70 Pro/S70S/S70VO/S60S/S60N	Reference DeviceLegally marketedEPIQ 5/EPIQ 7 DiagnosticUltrasound System(K172607)	Remark
Probe 23	6V7	C10-4ec	/
Photo	Image: Ultrasound probe	Image: Ultrasound probe	/

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ProbeType	Micro-curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	3.0-10.0MHz	SEAnalysis 5
Indicationfor use	Trans-rectal, Trans-vaginal	Fetal/OB,Trans-rectal,Trans-vaginal, Peripheralvessel, Other: GYN/Urology	Same
OperationMode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SEAnalysis 6
AcousticOutputLimits	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Derated ISPTA: 720mW/cm2maximumTIS/TIB/TIC: 6.0 maximumMI: 1.9 maximum	Same
Functions	Compound Imaging, ContrastImaging, Elastography	Compound Imaging,CPA,harmonic Imaging, ContrastImaging, 3D/4DImaging,XRES	SEAnalysis 7

SE Analysis 5:

Although the frequency is different, all of them comply with the requirements of IEC 60601-1 & IEC 60601-1-2 & IEC 60601-2-37 and meet clinical requirements, and no new risk is raised.

SE Analysis 6:

Although the operation mode is different, the new operation mode of DPDI (Directional Power Doppler Imaging) is similar to the PDI mode sequence with direction, and no new risk is raised.

SE Analysis 7:

Although the functions is different, the functions of the subject device are included in the predicated device, and no new risk is raised.

Moreover, compared with predicate device, the subject device (S60 Elite Series/S70 Series) complies with the same regulation and safety standards and has the consistent acoustic output levels.

Summary of the comparison

Compared with the predicate device legally marketed SonoScape S60 Series (K172082), Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems (K172607) and SonoScape P10 Series (K173058), the subjective device (S60 Elite Series/S70 Series

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Digital Color Doppler Ultrasound System) are all analyzed with the predicate device. The comparison showed that they can be considered Substantially Equivalent in safety and effectiveness. Therefore, there is no new risk raised, and the SE is not affected.

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

Non-clinical testing to assure compliance with electrical, mechanical, thermal and electromagnetic compatibility safety, acoustic output and biocompatibility were performed and have been found to conform to applicable standards. The S60 Elite Series/S70 Series 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];

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2 General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests [2014-02];

IEC 60601-2-37:2015 Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [Edition 2.1. 2015]:

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].

The Digital Color Doppler Ultrasound System is verified through the relevant

Performance test	Testing protocols andfail/acceptance criteria	Testing results
Electrical safety testing	IEC 60601-1:2005+A1:2012	Passed
EMC testing	IEC 60601-1-2:2014	Passed
Acoustic testing	IEC 60601-2-37:2015AIUM/NEMA UD 2:2004 (R2009)	Passed
Software Verification andValidation	IEC 62304:2006 +A 1:2015	Passed

summarized information as followed:

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Laboratory tests (including Phantom tests) were conducted to verify that the S60 Elite Series/S70 Series system met all design specifications and the S60 Elite Series/S70 Series system conformed to applicable medical device standards.

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 S60 Elite Series/S70 Series 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.