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

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.

Predicate Devices

K172082

Reference Devices

K172607, K173058

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and post-processing techniques without mentioning AI or ML.

Therapeutic

No.
This device is described as a diagnostic ultrasound system, which is used to generate images of internal structures for clinical diagnosis, not for therapeutic interventions.

Diagnostic

Yes
The device is described as an "integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications" and a "color diagnostic ultrasound system." The "Intended Use" section explicitly states its purpose is for "evaluation" of various anatomical sites, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and lists hardware components such as a "mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes." This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this device is an ultrasound system that transmits ultrasonic energy into the patient's body and processes the received echoes to generate images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
• Intended Use: The intended use describes the evaluation of various anatomical sites within the patient's body using ultrasound imaging. This aligns with in vivo diagnostics.

Therefore, the SonoScape S60 Elite Series Digital Color Doppler Ultrasound System is a diagnostic imaging device, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

IYN, IYO, ITX

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician / hospital or medical clinic

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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, IEC 60601-1-2:2014, IEC 60601-2-37:2015, ISO 10993-5:2009, ISO 10993-10:2010, AIUM/NEMA UD 2:2004 (R2009). All tests passed. 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. No clinical testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172082

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K172607, K173058

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

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

1

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

2

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 Ultrasound
System |
|--------------|--------------------------------------------------------------------------------------------------------------------------------|
| Models: | S60 Expert, S60 Classic, S60 Nov, S60 Super, S60 Speci, S60
Elite, 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

4

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,

5

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.

6

| Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60 Super/S60
Speci/S60 Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Primary Predicate Device
Legally marketed
SonoScape S60 Exp/S60/S60
Pro/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

7

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	SE
Analysis 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.

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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

| Probe

Type	Curved Array	Curved Array	Same
Frequency	1.0-7.0MHz	2.0-6.0MHz	SE
Analysis 5
Indication
for use	Fetal,
Other(Ob/GYN),
Abdominal,	General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications	Same
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound
Imaging,
Contrast
Imaging,
Elastography	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D
Imaging,
XRES, Elastography	SE
Analysis 7

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Primary Predicate Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------|
| Probe 2 | C1-6A | C6-2 | / |
| Photo | Image: C1-6A Probe | Image: C6-2 Probe | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 1.0-8.0MHz | 2.0-6.0MHz | SE
Analysis 5 |

11

510(k) Submission

| Indication
for use | Fetal,
Other(Ob/GYN) | Abdominal, | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
|------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Operation
Mode | B,THI,M,CFM,PDI,DPDI, PW | B,THI,M,CFM,PDI,PW | | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | | Same |
| Functions | Compound Imaging,
Contrast
Elastography | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography | | SE
Analysis 7 |

Table 3 d) Further Comparison for C1-6 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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 | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 1.0-8.0MHz | 2.0-6.0MHz | SE
Analysis 5 |
| Indication
for 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
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging,
Contrast Imaging,
Elastography	Compound Imaging,
CPA,
harmonic Imaging, Contrast Imaging,
3D/4D Imaging,
XRES, Elastography	SE
Analysis 7

Table 3 e) Further Comparison for C2-9 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 4 | C2-9 | C6-2 | / |
| Photo | Image: Ultrasound probe C2-9 | Image: Ultrasound probe C6-2 | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 2.0-13.0MHz | 2.0-6.0MHz | SE
Analysis 5 |
| Indication
for use | Fetal, Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |

13

510(k) Submission

| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
|------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|
| Functions | Compound Imaging,
Contrast Imaging | Compound Imaging, CPA,
harmonic Imaging, Contrast Imaging,
3D/4D Imaging,
XRES, Elastography | SE
Analysis 7 |

Table 3 f) Further Comparison for C322 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 5 | C322 | C6-2 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe | / |
| Probe
Type | Micro-curved Array | Curved Array | Same |
| Frequency | 2.0-7.0MHz | 2.0-6.0MHz | SE
Analysis 5 |
| Indication
for use | Fetal,
Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |

14

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

-----------	------------------------------------	------------------------------------------------------------------------------------------------------------	----------------------

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 6 | 6CT-A | C6-2 | / |
| Photo | Image: 6CT-A Probe | Image: C6-2 Probe | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 3.0-15.0MHz | 2.0-6.0MHz | SE
Analysis 5 |
| Indication
for use | Fetal,
Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging,
THI,
Contrast Imaging | Compound Imaging,
CPA,
harmonic Imaging,
Contrast
Imaging,
3D/4D
Imaging, | SE
Analysis 7 |

15

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 7 | 6CI-A | C6-2 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Probe | / |
| Probe
Type | Curved Array | Curved Array | Same |
| Frequency | 3.0-15.0MHz | 2.0-6.0MHz | SE
Analysis 5 |
| Indication
for use | Fetal, Abdominal,
Other(Ob/GYN) | General purpose abdominal
(adult and pediatric, including
vascular), bowel, obstetrical,
gynecological, prostate and
interventional applications | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, THI,
Contrast Imaging | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography | SE
Analysis 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/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 8 | 12L-A | L12-5 50 | / |
| Photo | Image: 12L-A | Image: L12-5 50 | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 3.0-17.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for 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 |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2 maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2 maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging, Elastography | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography | SE
Analysis 7 |

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70 | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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	/
Probe
Type	Linear Array	Linear Array	Same
Frequency	3.0-17.0MHz	5.0-12.0MHz	SE
Analysis 5
Indication
for 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
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging, Elastography	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography	SE
Analysis 7

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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

| Probe

Type	Linear Array	Linear Array	Same
Frequency	2.0-13.0MHz	5.0-12.0MHz	SE
Analysis 5
Indication
for 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
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging, Elastography	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging,
3D/4D
Imaging,
XRES, Elastography	SE
Analysis 7

Table 3 I) Further Comparison for L3-9 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------|
| Probe 11 | L3-9 | L12-5 50 | / |
| Photo | Image: Ultrasound probe | Image: Ultrasound probe | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 2.0-13.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for use | Small Organ (breast, thyroid,
testes),
Musculo-skeletal
(Conventional & Superficial), | Breast, thyroid and superficial
small parts; musculoskeletal
tendon, abdomen bowel, and | Same |

19

	Peripheral vessel	vascular applications
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging, Elastography	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography	SE
Analysis 7

Table 3 m) Further Comparison for L741 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 12 | L741 | L12-5 50 | / |
| Photo | Image: Ultrasound probe L741 | Image: Ultrasound probe L12-5 50 | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for 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 |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |

20

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

-----------	-----------------------------------------------------	-------------------------------------------------------------------------------------------------------	------------------

Table 3 n) Further Comparison for L742 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 13 | L742 | L12-5 50 | / |
| Photo | Image: Ultrasound probe | Image: Ultrasound probe | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for 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 |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging, Elastography | Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES, Elastography | SE
Analysis 7 |

Table 3 o) Further Comparison for 10I2 Probe

21

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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 | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for 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 |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging | Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES Elastography | SE
Analysis 7 |

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

| Comparis

on Items	Subject Device	Reference Device	Remark
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/	Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607)

22

510(k) Submission

| | S70/S70 Pro/S70S/S70
VO/S60S/S60N | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 15 | 12LT-A | L12-5 50 | / |
| Photo | Image: 12LT-A Probe | Image: L12-5 50 Probe | / |
| Probe
Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE
Analysis 5 |
| Indication
for 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 |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES, Elastography | SE
Analysis 7 |

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

| Comparis

on Items	Subject Device	Reference Device	Remark
	SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N	Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607)
	Probe 16	12LI-A	L12-5 50	/

23

510(k) Submission

Photo	Image: Ultrasound probe	Image: Ultrasound probe	/
Probe
Type	Linear Array	Linear Array	Same
Frequency	4.0-16.0MHz	5.0-12.0MHz	SE
Analysis 5
Indication
for 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
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging	Compound Imaging,
CPA,
harmonic Imaging,
Contrast
Imaging,
3D/4D
Imaging,
XRES, Elastography	SE
Analysis 7

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Probe 17 | 4P-A | S5-1 | / |
| Photo | Image: 4P-A Probe | Image: S5-1 Probe | / |
| Probe
Type | 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 | SE
Analysis 5 |
|------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------|
| Indication
for use | Abdominal, Cephalic, Cardiac | Abdominal, Cephalic, Cardiac | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES | SE
Analysis 7 |

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

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------|
| Probe 18 | 3P-A | S5-1 | / |
| Photo | Image: 3P-A probe | Image: S5-1 probe | / |
| Probe
Type | Phased Array | Phased Array | Same |
| Frequency | 1.0-6.0MHz | 1.0-5.0MHz | SE
Analysis 5 |
| Indication
for use | Abdominal, Cephalic, Cardiac | Abdominal, Cephalic, Cardiac | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/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	SE
Analysis 7

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound 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 | / |
| Probe
Type | Phased Array | Phased Array | Same |
| Frequency | 1.0-7.0MHz | 1.0-5.0MHz | SE
Analysis 5 |
| Indication
for use | Abdominal, Cephalic, Cardiac | Abdominal, Cephalic, Cardiac | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging | Compound Imaging, CPA,
harmonic Imaging,
Contrast
Imaging, 3D/4D
Imaging,
XRES | SE
Analysis 7 |

Table 3 t) Further Comparison for S1-5 Probe

Table 3 u) Further Comparison for VE9-5 Probe

26

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------|
| Probe 20 | VE9-5 | C10-3v | / |
| Photo | Image: VE9-5 | Image: C10-3v | / |
| Probe
Type | Micro-curved Array | Curved Array | Same |
| Frequency | 2.0-13.0MHz | 3.0-10.0MHz | SE
Analysis 5 |
| Indication
for use | Trans-vaginal | Fetal/OB,
Trans-vaginal,
Other: GYN/Urology | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging, 3D/4D | Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES | SE
Analysis 7 |

Table 3 v) Further Comparison for 6V1 Probe

| Comparis

on Items	Subject Device	Reference Device	Remark
	SonoScape S60 Expert/S60	Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607)
	Classic/S60 Nov/S60		Remark
	Super/S60 Speci/S60
	Elite/S-Light/S70 Exp/

27

510(k) Submission

| | S70/S70 Pro/S70S/S70
VO/S60S/S60N | | |
|------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------|
| Probe 21 | 6V1 | C10-4ec | / |
| Photo | Image: 6V1 Probe | Image: C10-4ec Probe | / |
| Probe
Type | Micro-curved Array | Curved Array | Same |
| Frequency | 3.0-15.0MHz | 3.0-10.0MHz | SE
Analysis 5 |
| Indication
for use | Trans-rectal, Trans-vaginal | Fetal/OB,
Trans-rectal,
Trans-vaginal,
Peripheral
vessel, Other: GYN/Urology | Same |
| Operation
Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE
Analysis 6 |
| Acoustic
Output
Limits | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast
Imaging | Compound Imaging,
CPA,
harmonic Imaging,
Contrast
Imaging,
3D/4D
Imaging,
XRES | SE
Analysis 7 |

Table 3 w) Further Comparison for 6V3 Probe

	Subject Device	Reference Device
Comparis
on Items	SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N	Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607)	Remark
	Probe 22	6V3	C10-4ec	/

28

Photo
Probe
Type	Micro-curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	3.0-10.0MHz	SE
Analysis 5
Indication
for use	Trans-rectal, Trans-vaginal	Fetal/OB,
Trans-rectal,
Trans-vaginal,
Peripheral
vessel, Other: GYN/Urology	Same
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging, Elastography	Compound Imaging, CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D Imaging,
XRES	SE
Analysis 7

Table 3 x) Further Comparison for 6V7 Probe

| Comparis
on Items | Subject Device
SonoScape S60 Expert/S60
Classic/S60 Nov/S60
Super/S60 Speci/S60
Elite/S-Light/S70 Exp/
S70/S70 Pro/S70S/S70
VO/S60S/S60N | Reference Device
Legally marketed
EPIQ 5/EPIQ 7 Diagnostic
Ultrasound System
(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Probe 23 | 6V7 | C10-4ec | / |
| Photo | Image: Ultrasound probe | Image: Ultrasound probe | / |

29

| Probe

Type	Micro-curved Array	Curved Array	Same
Frequency	3.0-15.0MHz	3.0-10.0MHz	SE
Analysis 5
Indication
for use	Trans-rectal, Trans-vaginal	Fetal/OB,
Trans-rectal,
Trans-vaginal, Peripheral
vessel, Other: GYN/Urology	Same
Operation
Mode	B,THI,M,CFM,PDI,DPDI,PW	B,THI,M,CFM,PDI,PW	SE
Analysis 6
Acoustic
Output
Limits	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Derated ISPTA: 720mW/cm2
maximum
TIS/TIB/TIC: 6.0 maximum
MI: 1.9 maximum	Same
Functions	Compound Imaging, Contrast
Imaging, Elastography	Compound Imaging,
CPA,
harmonic Imaging, Contrast
Imaging, 3D/4D
Imaging,
XRES	SE
Analysis 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

30

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 and
fail/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 60601-2-37:2015
AIUM/NEMA UD 2:2004 (R2009) | Passed |
| Software Verification and
Validation | IEC 62304:2006 +A 1:2015 | Passed |

summarized information as followed:

31

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.