February 10, 2023

Sonoscape Medical Corp.

℅ Toki Wu
Regulatory Affairs Manager
Room 201 & 202, 12th Building, Shenzhen Software Park Phase II
1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha District
Shenzhen, Guangdong 518057
CHINA

Re: K222596
Trade/Device Name: S90 Exp 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: December 26, 2022
Received: January 4, 2023

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.05.02
Silver Spring, MD 20993
www.fda.gov
K222596 - Toki Wu Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) 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-reporting-
combination-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-devices/medical-device-safety/medical-device-reporting-
mdr-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/medical-
devices/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-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yanna S. Kang -S
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K222596

Device Name
S90 Exp Series Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The S90 Exp Series Digital Color Doppler Ultrasound System (S90 Exp, S80, S80T, S80 Pro, S80 Exp, S80 Plus, S80
Elite, S80 Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80T, P80 Pro, P80 Exp, P80 Plus, P80 Elite, P80 Senior, P80
Super, P70i, I80-Endo, I80-Surg, I75-Endo, I70-Endo) is a general-purpose ultrasonic imaging instrument intended for
use by a qualified physician or sonographer with sufficient clinical ultrasound training for ultrasound imaging,
measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical
clinic. The system is applicable for people who need clinical ultrasound examination.
The system is intended for use in the following clinical applications: 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-esophageal (Cardiac),
Laparoscopic, OB/Gyn and Urology.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler,
Directional Power Doppler, Tissue Harmonic Imaging, Tissue Doppler Imaging, 3D/4D Imaging mode, Strain
Elastography, Shear Wave Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M, B/Color
Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

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

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
SONOSCAPE MEDICAL CORP. 510(k) Submission

510(k) Summary
K222596
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
Tel: +86 755 26722890
Fax: +86 755 26722850
Email: [email protected]
Date Revised February 10, 2023

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

Trade Name: S90 Exp Series Digital Color Doppler Ultrasound System
Models: S90 Exp, S80, S80T, S80 Pro, S80 Exp, S80 Plus, S80 Elite, S80
Senior, S80 Super, S70i, S100 Exp, P90i, P80, P80T, P80 Pro, P80
Exp, P80 Plus, P80 Elite, P80 Senior, P80 Super, P70i, I80-Endo,
I80-Surg, I75-Endo, I70-Endo
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 Elite Series/S70 Series K201059

510(k) Summary Page 1 of 7

SONOSCAPE MEDICAL CORP. 510(k) Submission

Device MEDICAL Digital Color Doppler

CORP. Ultrasound System
Reference device SONOSCAPE P60 Series Digital Color K171000
MEDICAL Doppler Ultrasound System
CORP.
Reference device SONOSCAPE P20 Elite Series Digital Color K221140
MEDICAL Doppler Ultrasound System
CORP.
Reference device Shenzhen Resona 7 Diagnostic K171233
Mindray Ultrasound System
Bio-Medical
Electronics Co.,
LTD
Reference device Shenzhen Resona R9 series Diagnostic K202785
Mindray Ultraosund System
Bio-Medical
Electronics Co.,
LTD
Reference device DiA Imaging LVivo Software Application K210053
Analysis Ltd.

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

This SonoScape S90 Exp 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
510(k) Summary Page 2 of 7
SONOSCAPE MEDICAL CORP. 510(k) Submission

Doppler Imaging, or the combination of these modes, Contrast Imaging, Strain

Elastography, Shear Wave Elastography (S-SWE, P-SWE), SonoFusion, 3D/4D.

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

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging

instrument intended for use by a qualified physician or sonographer with sufficient
clinical ultrasound training for ultrasound imaging, measurement, display and analysis
of the human body and fluid, which is intended to be used in a hospital or medical clinic.
The system is applicable for people who need clinical ultrasound examination.
The system is intended for use in the following clinical applications: 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-esophageal
(Cardiac), Laparoscopic, OB/Gyn and Urology.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M
Doppler, Power Doppler, Directional Power Doppler, Tissue Harmonic Imaging, Tissue
Doppler Imaging, 3D/4D Imaging mode, Strain Elastography, Shear Wave
Elastography, Contrast and Combined modes: B/M, B/PWD, B/THI, M/Color M,
B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD.

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

S90 Exp Series Digital Color Doppler Ultrasound System is comparable with and
substantially equivalent to the predicate devices:
Type Manufacturer Device 510 (K) Number
Primary Predicate SONOSCAPE S60 Elite Series/S70 Series K201059
Device MEDICAL CORP. Digital Color Doppler
Ultrasound System
Reference device SONOSCAPE P60 Series Digital Color K171000
MEDICAL CORP. Doppler Ultrasound System
Reference device SONOSCAPE P20 Elite Series Digital K221140
MEDICAL CORP. Color Doppler Ultrasound
System
Reference device Shenzhen Resona 7 Diagnostic K171233
Mindray Ultrasound System
Bio-Medical
Electronics Co.,
510(k) Summary Page 3 of 7
SONOSCAPE MEDICAL CORP. 510(k) Submission

LTD
Reference device Shenzhen Resona R9 series K202785
Mindray Diagnostic Ultraosund
Bio-Medical System
Electronics Co.,
LTD
Reference device DiA Imaging LVivo Software Application K210053
Analysis Ltd.
S90 Exp Series Digital Color Doppler Ultrasound System has almost the same intended
uses, complies with the same regulation and safety standards, has the consistent
acoustic output levels, and has similar probes and technical characteristics with the
primary predicate device legally marketed S60 Elite Series/S70 Series (K201059).

Intended Use Comparison:

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series has almost the same intended use. There are some
additional information for subject device, including patient population and etc., but all of
them are also the same between the subject device and the primary predicate device.
Regulation and Safety Standards Comparison:

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series comply with the same regulation and safety standards.

Acoustic Output Levels Comparison:

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series have the consistent acoustic output levels.

Probes Comparison:
Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series have the similar probes. There are twelve new probes,
including C1-6A-M, C2-9-M, MC1-6, MC1-6-M, VC2-9A, EC9-5, BCL10-5-M and
VE3-10, L2-9, L2-9-M, L3-11 and CWD5.0.

The new probes VC2-9A, EC9-5, VE3-10 and CWD5.0 has been cleared in the P60
Series Digital Color Doppler Ultrasound System (K171000) and other series,
manufactured by SONOSCAPE MEDICAL CORP.

The new probes C1-6A-M, C2-9-M, MC1-6, MC1-6-M, BCL10-5-M, L2-9, L2-9-M and

510(k) Summary Page 4 of 7

SONOSCAPE MEDICAL CORP. 510(k) Submission

L3-11 have the same technical characteristics as the probe C1-6A, C2-9, C322,
BCL10-5, L3-9 or 9L-A respectively, including probe type, central frequency, indications
for use, operation mode, material and manufacturing process. There is only small
difference in appearance or size, which doesn’t affect the safety, effectiveness and
clinical use. There is no new risk raised in safety and effectiveness of the new probes.
Therefore they can be considered Substantially Equivalent in safety and effectiveness,
so the SE is not affected.

Biopsy bracket Comparison:

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series have five new biopsy brackets NGBMC1-6, NGBEC9-5,
NGBVE3-10, NGBL2-9 and NGBL3-11.

Compared with NGB3C-A, the new biopsy brackets have the same material,
manufacturing process and reprocessing procedures, and have similar design and
appearance; there is only small difference in the size among them, which doesn’t affect
reprocessing procedures. There is no new risk raised in safety and effectiveness of the
new biopsy brackets. Therefore they can be considered Substantially Equivalent in
safety and effectiveness, so the SE is not affected.

Technical Characteristics Comparison:

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series have almost the same main technical features,
including Design, Operation Controls, Operation Mode and Display Modes.

Compared with the predicate device S60 Elite Series/S70 Series (K201059), the
Subject Device S90 Exp Series have some new features in Function, including Shear
Wave Elastography, SonoFusion and Auto Cardiac Measurement (LVivo EF and LVivo
RV), which are equivalent with the functions of the predicated devices.

The Shear Wave Elastography function in probes (C1-6A, C1-6A-M, 12L-A, 12L-B, L2-9,
L2-9-M, L3-11, 6V3 and 6V7) is equivalent with the STE and STQ function in probes
(SC6-1U, C6-2GU, L11-3U and V11-3HU) cleared with reference device Resona 7
Diagnostic Ultrasound System (K171233, K202785).

The SonoFusion function in probes (C1-6A and C1-6A-M) is equivalent with the
Ultrasound fusion imaging and Needle Navigation function in probes (SC6-1U) cleared
with reference device Resona 7 Diagnostic Ultrasound System (K171233).

The Auto Cardiac Measurement (LVivo EF and LVivo RV) function is the same as the

510(k) Summary Page 5 of 7

SONOSCAPE MEDICAL CORP. 510(k) Submission

function of the predicated device LVivo Software Application (K210053).

The differences in function will not raise new risk and different questions of safety and
effectiveness. Therefore they can be considered Substantially Equivalent in safety and
effectiveness, the SE is not affected.

Summary of the comparison

Compared with the predicate devices, the subject device (S90 Exp Series 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 S90 Exp
Series 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
summarized information as followed:
Performance test Testing protocols and Testing results

510(k) Summary Page 6 of 7

SONOSCAPE MEDICAL CORP. 510(k) Submission

fail/acceptance criteria
Electrical safety testing IEC 60601-1:2005+A1:2012 Passed
EMC testing IEC 60601-1-2:2014 Passed
Acoustic testing IEC 60601-2-37:2007+A1:2015 Passed
AIUM/NEMA UD 2:2004 (R2009)
Software Verification and IEC 62304:2006 +A1:2015 Passed
Validation

Laboratory tests (including Phantom tests) were conducted to verify that the S90 Exp
Series met all design specifications and the S90 Exp Series 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 S90 Exp Series
Digital Color Doppler Ultrasound System is substantially equivalent to the predicate
device with regard to safety and effectiveness.

510(k) Summary Page 7 of 7