Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities in its description, intended use, or performance studies.

Therapeutic

No.
The device is described as a diagnostic ultrasound system intended for imaging anatomical structures, not for treating any condition.

Diagnostic

Yes
The "Device Description" section states that the device is a "portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system." It also mentions its use for "examining the adult, pregnant woman, and children" and for "general clinical applications including fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging," all of which point to diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a software component (the app) and a hardware component (the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer).

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 a "diagnostic ultrasound system" that uses "pulsed-echo technology to transmit ultrasound images" of "anatomic structures and fluid flow within the body." It works by transmitting sound waves into the patient's body and processing the reflected echoes.
Lack of sample analysis: There is no mention of the device analyzing any samples taken from the patient's body. It directly interacts with the patient's body to generate images.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.
The modes of operation are B-mode, PDI(Power Doppler Imaging) mode, PW(Pulse Wave Spectral Doppler) mode and Harmonic mode.

Product codes

IYN, IYO, ITX

Device Description

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.

The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).

The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, pregnant woman, and children

Intended User / Care Setting

Intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings.

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)

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
IEC 60601-1:2005. AMD1:2012 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
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
IEC 60601-2-37: 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 14971: 2007 Medical devices - Application of risk management to medical devices
IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1: 2015 Medical devices - Part 1: Application of usability engineering to medical devices
ISO15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling. and information to be supplied - Part 1: General requirements

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

Not Found

Predicate Device(s)

K172750, K151339, K171926, K170085

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

October 11, 2022

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Bionet Co., Ltd. % ChuelWon Lee RA Manager 5F, 61 Digital-ro 31-gil Guro-gu Seoul, 08375 REPUBLIC OF KOREA

Re: K220169

Trade/Device Name: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 19, 2022 Received: September 20, 2022

Dear ChuelWon Lee:

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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT 8C: 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

2

Indications for Use

510(k) Number (if known) K220169

Device Name

SonoMe Wireless Probe Type Ultrasound Scamer (Model: 5C, 5CB, H5C, 10L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Indications for Use (Describe)

SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.

The modes of operation are B-mode, PDI(Power Doppler Imaging) mode, PW(Pulse Wave Spectral Doppler) mode and Harmonic mode.

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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3

Image /page/3/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in lowercase letters, with a stylized blue butterfly above the word. The word "bionet" is in a sans-serif font and is black. The butterfly is a light blue color and has a simple, elegant design.

K220169

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided.

1. Submitter
Submitter:	Bionet Co., LTD
5F, 61 Digital-ro 31-gil
Guro-gu, Seoul, Republic of Korea [08375]
Connect:	Primary Contact Person Name: ChuelWon Lee
5F, 61 Digital-ro 31-gil
Guro-gu, Seoul, Republic of Korea [08375]
Tel: +82.70.7585.6459 or +82.10.2067.2442
Email: cwlee@ebionet.com

Secondary Contact Person Name: Robbin
5F, 61 Digital-ro 31-gil
Guro-gu, Seoul, Republic of Korea [08375]
Tel: +82.10.2067.2442
Email: shpark @ebionet.com |
| Date Prepared: | January 17, 2022 |

2. Proposed Device

| Device Name | Wireless Probe Type Ultrasound Scanner
(Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Trade Name | SonoMe |
| Regulation Number | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Regulation Name | Ultrasonic pulsed doppler imaging system
Ultrasonic pulsed echo imaging system
Diagnostic ultrasonic transducer |
| Product Code | IYN, IYO, ITX |
| Regulatory Class | Class II |

| Device Name | Wireless Probe Type Ultrasound Scanner
(Model: SF14L25) |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Trade Name | SONOFINDER |
| Regulation Number | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Regulation Name | Ultrasonic pulsed doppler imaging system
Ultrasonic pulsed echo imaging system
Diagnostic ultrasonic transducer |
| Product Code | IYN, IYO, ITX |
| Regulatory Class | Class II |

4

Image /page/4/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with a stylized blue butterfly above the word. The butterfly is positioned slightly to the left of the word "bionet". The overall design is simple and modern.

3. Predicate Device

Type	Proposed Device	Predicate Device:
Convex	Model: 5C, 5CB, H5C	Wireless Probe Type Ultrasound Scanner /
Model: UProbe-C (K172750)
SONON Ultrasound Imaging System / Model:
SONON 300C (K151339)
C5 Diagnostic Ultrasound System (K171926)
Linear	Model: 10L, 14L, 10LB, H10L, SF14L25	Wireless Probe Type Ultrasound Scanner /
Model: UProbe-L (K172750)
SONON Ultrasound Imaging System / Model:
SONON 300L (K170085)
C5 Diagnostic Ultrasound System (K171926)
Dual	Model: H5C10L	Wireless Probe Type Ultrasound Scanner /
Model: UProbe-C (K172750)
SONON Ultrasound Imaging System / Model:
SONON 300C (K151339)
C5 Diagnostic Ultrasound System (K171926)
Wireless Probe Type Ultrasound Scanner /
Model: UProbe-L (K172750)
SONON Ultrasound Imaging System / Model:
SONON 300L (K170085)
C5 Diagnostic Ultrasound System (K171926)

4. Device Description

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.

The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).

The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.

5. Indications for use

SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are

5

Image /page/5/Picture/0 description: The image shows the logo for Bionet. The logo features a light blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is stylized with rounded wings, and the overall design is clean and modern.

intended in hospital clinic, and medical office settings. The general clinical applications include fetal/obstetrics(OB). gynecology(GYN), abdominal, small organ and peripheral vessel imaging, The modes of operation are B-mode, PDI(Power Doppler Imaging) mode, PW(Pulse Wave Spectral Doppler) mode and Harmonic mode.

6. Technology

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) employ the similar fundamental scientific technology as its predicate device(s).

7. Determination of Substantial Equivalence

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are substantially equivalent to the predicate devices with regards to intended use, principles of operation, technological characteristics and safety and effectiveness.

As described below, the system has been evaluated for acoustic output, biocompatibility, thermal, electrical, and mechanical safety, and has been found to conform to applicable standards and product specifications that demonstrate that the SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are substantially equivalent to the predicate devices.

6

Image /page/6/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly with a light blue color. The butterfly is positioned slightly to the left of the word "bionet".

Comparison Table:

Model: 5C, 5CB, H5C

| Comparison

Items	Subject Device			Predicate Device
Device Name /
Model Name	Wireless Probe Type
Ultrasound Scanner /
Model: 5C
(Under Review)	Wireless Probe Type
Ultrasound Scanner /
Model: 5CB
(Under Review)	Wireless Probe Type
Ultrasound Scanner /
Model: H5C
(Under Review)	Wireless Probe Type
Ultrasound Scanner /
Model: UProbe-C
(K172750)	SONON Ultrasound
Imaging System /
Model: SONON 300C
(K151339)	C5 Diagnostic
Ultrasound System
(K171926)
Manufacturer	Bionet Co., Ltd.	Bionet Co., Ltd.	Bionet Co., Ltd.	Guangzhou Sonostar
Technologies Co.,
Ltd.	Healcerion Co., Ltd.	Guangzhou Sonostar
Technologies Co.,
Ltd.
Product Code	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYO, ITX	IYO, ITX	IYN, IYO, ITX
Classification	Class 2	Class 2	Class 2	Class 2	Class 2	Class 2
Indication for
Use	SonoMe is indicated
for examining the
adult, pregnant
woman, and children.
This products is
intended for use by, or
by the order of, and
under the supervision
of, a licensed
physician who is
qualified for direct use
of medical devices. An
appropriately trained
healthcare
professionals can have
operator
qualifications. The
device use settings are
intended in hospital
clinic, and medical
office settings. The
general clinical
applications include
fetal/obstetrics(OB),
gynecology(GYN)	SonoMe is indicated
for examining the
adult, pregnant
woman, and children.
This products is
intended for use by, or
by the order of, and
under the supervision
of, a licensed
physician who is
qualified for direct use
of medical devices. An
appropriately trained
healthcare
professionals can have
operator
qualifications. The
device use settings are
intended in hospital
clinic, and medical
office settings. The
general clinical
applications include
fetal/obstetrics(OB),
gynecology(GYN)	SonoMe is indicated
for examining the
adult, pregnant
woman, and children.
This products is
intended for use by, or
by the order of, and
under the supervision
of, a licensed
physician who is
qualified for direct use
of medical devices. An
appropriately trained
healthcare
professionals can have
operator
qualifications. The
device use settings are
intended in hospital
clinic, and medical
office settings. The
general clinical
applications include
fetal/obstetrics(OB),
gynecology(GYN)	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including obstetrics
(OB), gynecology
(GYN) and general
(abdominal) imaging.	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including obstetrics
(OB), gynecology
(GYN) and general
(abdominal) imaging.	C5 Diagnostic
Ultrasound System is
a general-purpose
ultrasonic imaging
instrument intended
for use by a qualified
physician for
evaluation for Fetal,
Abdominal, Pediatric,
Small Organ (breast,
testes, thyroid), Trans-
vaginal, Peripheral
Vascular, Musculo-
skeletal (Conventional
and Superficial),
Cardiac (neonatal and
adult), OB/Gyn and
Urology.
Comparison
Items	Subject Device			Predicate Device
	abdominal, small
organ and peripheral
vessel imaging.
The modes of
operation are B-mode,
PDI(Power Doppler
Imaging) mode,
PW(Pulse Wave
Spectral Doppler)
mode and Harmonic
mode.	abdominal, small
organ and peripheral
vessel imaging.
The modes of
operation are B-mode,
PDI(Power Doppler
Imaging) mode,
PW(Pulse Wave
Spectral Doppler)
mode and Harmonic
mode.	abdominal, small
organ and peripheral
vessel imaging.
The modes of
operation are B-mode,
PDI(Power Doppler
Imaging) mode,
PW(Pulse Wave
Spectral Doppler)
mode and Harmonic
mode.	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings
Environment
of Use	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Track 3	Track 3
Acoustic
Output Levels	Track 3	Track 3	Track 3	B	B, M, **PW, Color,
*PDI, Compound
Imaging
Display mode	B, B/M, Color, *PDI,
**PW	B, B/M	B, B/M, Color, *PDI,
**PW	For use in all patients	For use in all patients
Patient
Population	For use in all patients	For use in all patients	For use in all patients	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	Fetal, Abdominal,
Pediatric, Small Organ
(breast, testes,
thyroid), Trans-
vaginal, Peripheral
Vascular, Musculo-
skeletal (Conventional
and Superficial),
Cardiac (neonatal and
adult), OB/Gyn and
Urology.
Clinical
application	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	Healthcare
professionals	Healthcare
professionals
Users	Healthcare
professionals	Healthcare
professionals	Healthcare
professionals	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the	The basic principle is
that system transmits
ultrasonic energy into
patient body and
implements post
Principle/
Method of
Operation	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
Comparison
Items	Subject Device				Predicate Device
Image Display
Unit	body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.
Mobile device (4 to 13 inches approximately)	body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.
Mobile device (4 to 13 inches approximately)	body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.
Mobile device (4 to 13 inches approximately)	body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.
Mobile device (4 to 13 inches approximately)	body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as image of anatomic structures.
Mobile device (4 to 10 inches approximately)	processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
15-inch LCD monitor
Probe
Characteristics	Convex, 3.2/5MHz frequency	Convex, 3.2/5MHz frequency	Convex, 3.2/5MHz frequency	Convex, 3.5MHz frequency	Convex, 3.5MHz frequency	Supporting Linear probes (7.5MHz & 6.5MHz) and convex array probes (3.5MHz & 5.0MHz)
Probe
Connection to
Display	Wireless	Wireless	Wireless	Wireless	Wireless	Non wireless
Off-the-shelf
operation
system	iOS / Android / Windows	iOS / Android / Windows	iOS / Android / Windows	iOS	iOS / Android	Linux
Software	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device	Based on an embedded Linux Operating System
System
Components	Commercial off-the-shelf iOS mobile device
Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device
Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates	Commercial off-the-shelf iOS mobile device
Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device
Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates	Commercial off-the-shelf iOS mobile device
Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device
Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates	Commercial off-the-shelf iOS mobile device
Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device
Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates	Commercial off-the-shelf iOS or Android mobile device
SONON Ultrasound Imaging System software that runs as an app on the mobile device
SONON Ultrasound Imaging System battery-operated, hand-held ultrasound diagnostic transducer that communicates	The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging system
Comparison
Items	Subject Device			Predicate Device
	wirelessly with Tablet
PC or Mobile Phone
which supports by
iOS, Android OS or
Windows System.	wirelessly with Tablet
PC or Mobile Phone
which supports by
iOS, Android OS or
Windows System.	wirelessly with Tablet
PC or Mobile Phone
which supports by
iOS, Android OS or
Windows System.	wirelessly with iOS
mobile device	wirelessly with iOS or
Android mobile
device	All materials with
patient contact are
biocompatible and can
be disinfected
Patient
Contacting
Materials	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Evaluated according
to FDA recognized
standards - ISO
10993-5 and ISO
10993-10	All materials with
patient contact are
biocompatible and can
be disinfected	All materials with
patient contact are
biocompatible and can
be disinfected
Electrical
Safety	Evaluated according
to IEC 60601-1			Evaluated according
to IEC 60601-1
EMC	Evaluated according
to IEC 60601-1-2			Evaluated according
to IEC 60601-1-2
Performance
Safety	Evaluated according
to IEC 60601-2-37			Evaluated according
to IEC 60601-2-37

7

Image /page/7/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word is a stylized image of a butterfly with a gradient of blue colors. The butterfly is positioned so that it appears to be flying upwards and to the right.

8

Image /page/8/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase as well. Above the word "bionet" is a stylized image of a butterfly in a light blue color. The butterfly is positioned so that its wings are spread out, and it appears to be in flight.

9

Image /page/9/Picture/0 description: The image shows the logo for Bionet. The logo features a light blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is stylized with rounded wings, and the overall design is simple and modern.

*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler

Model: 10L, 14L, SF14L25, 10LB, H10L

| Comparison

Items	Subject Device					Predicate Device
Device Name /
Model Name	Wireless Probe
Type
Ultrasound
Scanner /
Model: 10L
(Under Review)	Wireless Probe
Type
Ultrasound
Scanner /
Model: 14L
(Under Review)	Wireless Probe
Type
Ultrasound
Scanner /
Model:
SF14L25
(Under Review)	Wireless Probe
Type
Ultrasound
Scanner /
Model: 10LB
(Under Review)	Wireless Probe
Type
Ultrasound
Scanner /
Model: H10L
(Under Review)	Wireless Probe
Type
Ultrasound
Scanner /
Model: UProbe-
L
(K172750)	SONON
Ultrasound
Imaging System
/ Model:
SONON 300L
(K170085)	C5 Diagnostic
Ultrasound
System
(K171926)
Manufacturer	Bionet Co., Ltd.	Bionet Co., Ltd.	Bionet Co., Ltd.	Bionet Co., Ltd.	Bionet Co., Ltd.	Guangzhou
Sonostar
Technologies
Co., Ltd.	Healcerion Co.,
Ltd.	Guangzhou
Sonostar
Technologies
Co., Ltd.
Product Code	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX
Classification	Class 2	Class 2	Class 2	Class 2	Class 2	Class 2	Class 2	Class 2
Indication for
Use	SonoMe is
indicated for
examining the	SonoMe is
indicated for
examining the	SONOFINDER
is indicated for
examining the	SonoMe is
indicated for
examining the	SonoMe is
indicated for
examining the	Intended for
diagnostic
ultrasound echo	Intended for
diagnostic
ultrasound echo	C5 Diagnostic
Ultrasound
System is a
Comparison
Items	Subject Device					Predicate Device
	adult, pregnant
woman, and
children. This
products is
intended for use
by, or by the
order of, and
under the
supervision of,
a licensed
physician who
is qualified for
direct use of
medical
devices. An
appropriately
trained
healthcare
professionals
can have
operator
qualifications.
The device use
settings are
intended in
hospital clinic,
and medical	adult, pregnant
woman, and
children. This
products is
intended for use
by, or by the
order of, and
under the
supervision of,
a licensed
physician who
is qualified for
direct use of
medical
devices. An
appropriately
trained
healthcare
professionals
can have
operator
qualifications.
The device use
settings are
intended in
hospital clinic,
and medical	adult, pregnant
woman, and
children. This
products is
intended for use
by, or by the
order of, and
under the
supervision of,
a licensed
physician who
is qualified for
direct use of
medical
devices. An
appropriately
trained
healthcare
professionals
can have
operator
qualifications.
The device use
settings are
intended in
hospital clinic,
and medical	adult, pregnant
woman, and
children. This
products is
intended for use
by, or by the
order of, and
under the
supervision of,
a licensed
physician who
is qualified for
direct use of
medical
devices. An
appropriately
trained
healthcare
professionals
can have
operator
qualifications.
The device use
settings are
intended in
hospital clinic,
and medical	adult, pregnant
woman, and
children. This
products is
intended for use
by, or by the
order of, and
under the
supervision of,
a licensed
physician who
is qualified for
direct use of
medical
devices. An
appropriately
trained
healthcare
professionals
can have
operator
qualifications.
The device use
settings are
intended in
hospital clinic,
and medical	imaging,
measurement,
and analysis of
the human body
for general
clinical
applications
including small
organ and
peripheral
vessel imaging.	imaging,
measurement,
and analysis of
the human body
for general
clinical
applications
including
musculoskeletal
(MSK),
vascular, small
parts (breast,
thyroid), and
thoracic/pleural
motion and
fluid detection
imaging.	general-purpose
ultrasonic
imaging
instrument
intended for use
by a qualified
physician for
evaluation for
Fetal, Abdominal,
Pediatric, Small
Organ (breast,
testes, thyroid),
Trans-vaginal,
Peripheral
Vascular,
Musculo-skeletal
(Conventional
and Superficial),
Cardiac (neonatal
and adult),
OB/Gyn and
Urology.
	office settings.
The general
clinical
applications
include
fetal/obstetrics(
OB),
gynecology(GY
N), abdominal,
small organ and
peripheral	office settings.
The general
clinical
applications
include
fetal/obstetrics(
OB),
gynecology(GY
N), abdominal,
small organ and
peripheral	office settings.
The general
clinical
applications
include
fetal/obstetrics(
OB),
gynecology(GY
N), abdominal,
small organ and
peripheral	office settings.
The general
clinical
applications
include
fetal/obstetrics(
OB),
gynecology(GY
N), abdominal,
small organ and
peripheral	office settings.
The general
clinical
applications
include
fetal/obstetrics(
OB),
gynecology(GY
N), abdominal,
small organ and
peripheral
Comparison
Items	Subject Device					Predicate Device
vessel imaging.
The modes of
operation are B-
mode,
PDI(Power
Doppler
Imaging) mode,
PW(Pulse Wave
Spectral
Doppler) mode
and Harmonic
mode.	vessel imaging.
The modes of
operation are B-
mode,
PDI(Power
Doppler
Imaging) mode,
PW(Pulse Wave
Spectral
Doppler) mode
and Harmonic
mode.	vessel imaging.
The modes of
operation are B-
mode,
PDI(Power
Doppler
Imaging) mode,
PW(Pulse Wave
Spectral
Doppler) mode
and Harmonic
mode.	vessel imaging.
The modes of
operation are B-
mode,
PDI(Power
Doppler
Imaging) mode,
PW(Pulse Wave
Spectral
Doppler) mode
and Harmonic
mode.	vessel imaging.
The modes of
operation are B-
mode,
PDI(Power
Doppler
Imaging) mode,
PW(Pulse Wave
Spectral
Doppler) mode
and Harmonic
mode.
Environment
of Use	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings	Hospital, clinic,
and medical
office settings
Acoustic
Output Levels	Track 3	Track 3	Track 3	Track 3	Track 3	Track 3	Track 3	Track 3
Display mode	B, B/M, Color,
PDI,* PW	B, B/M, Color,
PDI,* PW	B, B/M, Color,
PDI,* PW	B, B/M	B, B/M, Color,
PDI,* PW	B, B/M	B, Color	B, M, **PW,
Color, *PDI,
Compound
Imaging
Patient
Population	For use in all
patients	For use in all
patients	For use in all
patients	For use in all
patients	For use in all
patients	For use in all
patients	For use in all
patients	For use in all
patients
Clinical
application	General clinical
applications,
including small
organ and
peripheral
vessel	General clinical
applications,
including small
organ and
peripheral
vessel	General clinical
applications,
including small
organ and
peripheral
vessel	General clinical
applications,
including small
organ and
peripheral
vessel	General clinical
applications,
including small
organ and
peripheral
vessel	General clinical
applications,
including small
organ and
peripheral
vessel imaging.	General clinical
applications,
including
fetal/obstetrics,
gynecology,
abdominal	Fetal, Abdominal,
Pediatric, Small
Organ (breast,
testes, thyroid),
Trans-vaginal,
Peripheral
Vascular,
Musculo-skeletal
(Conventional
and Superficial),
Cardiac (neonatal
and adult),
OB/Gyn and
Urology.
Comparison
Items	Subject Device					Predicate Device
Users	Healthcare	Healthcare	Healthcare	Healthcare	Healthcare	Healthcare	Healthcare	Healthcare
	professionals	professionals	professionals	professionals	professionals	professionals	professionals	professionals
Principle	Piezoelectric	Piezoelectric	Piezoelectric	Piezoelectric	Piezoelectric	Piezoelectric	Piezoelectric	The basic
of
Method	material in the	material in the	material in the	material in the	material in the	material in the	material in the	principle is that
Operation	transducer is	transducer is	transducer is	transducer is	transducer is	transducer is	transducer is	system transmits
	used as an	used as an	used as an	used as an	used as an	used as an	used as an	ultrasonic energy
	ultrasound	ultrasound	ultrasound	ultrasound	ultrasound	ultrasound	ultrasound	into patient body
	source to	source to	source to	source to	source to	source to	source to	and implements
	transmit sound	transmit sound	transmit sound	transmit sound	transmit sound	transmit sound	transmit sound	post processing
	waves into the	waves into the	waves into the	waves into the	waves into the	waves into the	waves into the	of received
	body. Sound	body. Sound	body. Sound	body. Sound	body. Sound	body. Sound	body. Sound	echoes to
	waves are	waves are	waves are	waves are	waves are	waves are	waves are	generate onscreen
	reflected back	reflected back	reflected back	reflected back	reflected back	reflected back	reflected back	display of
	to the	to the	to the	to the	to the	to the	to the	anatomic
	transducer and	transducer and	transducer and	transducer and	transducer and	transducer and	transducer and	structures and
	converted to	converted to	converted to	converted to	converted to	converted to	converted to	fluid flow within
	electrical	electrical	electrical	electrical	electrical	electrical	electrical	the body.
	signals that are	signals that are	signals that are	signals that are	signals that are	signals that are	signals that are
	processed and	processed and	processed and	processed and	processed and	processed and	processed and
	displayed as	displayed as	displayed as	displayed as	displayed as	displayed as	displayed as
	image of	image of	image of	image of	image of	image of	image of
	anatomic	anatomic	anatomic	anatomic	anatomic	anatomic	anatomic
	structures.	structures.	structures.	structures.	structures.	structures.	structures.
Image Display	Mobile
device	Mobile
device	device
Mobile	Mobile	Mobile device	Mobile device	Mobile device	15-inch LCD
Unit	(4 to 13 inches	(4 to 13 inches	(4 to 13 inches	(4 to 13 inches	(4 to 13 inches	(4 to 13 inches	(4 to 10 inches	monitor
	approximately)	approximately)	approximately)	approximately)	approximately)	approximately)	approximately )
Probe	Linear.	Linear.	Linear.	Linear,	Linear.	Linear, 7.5MHz	Linear.	Supporting
Characteristics	7.5/10MHz	10/14MHz	10/14MHz	7.5/10MHz	7.5/10MHz	frequency	5/7.5/10MHz	Linear probes
	frequency	frequency	frequency	frequency	frequency		frequency	(7.5MHz &
								6.5MHz) and
								convex array
								probes (3.5MHz
								& 5.0MHz)
Probe	Wireless	Wireless	Wireless	Wireless	Wireless	Wireless	Wireless	Non wireless
Connection to
Display
Operation	iOS / Android /	iOS / Android /	iOS / Android /	iOS / Android /	iOS / Android /	iOS	iOS / Android	Linux
System	Windows	Windows	Windows	Windows	Windows
Comparison
Items	Subject Device					Predicate Device
Software	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Run as an app
on off-the-shelf
mobile device	Based on an
embedded Linux
Operating System
System
Components	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS mobile
device	Commercial
off-the-shelf
iOS or Android
mobile device	The C5
Diagnostic
Ultrasound
System is an
integrated
preprogrammed
color ultrasound
imaging system,
capable of
producing high
detail
resolution
intended for
clinical
diagnostic
imaging system
	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	Wireless Probe
Type
Ultrasound
Scanner
software that
runs as an app
on the mobile
device	SONON
Ultrasound
Imaging System
software that
runs as an app
on the mobile
device
	Wireless Probe
Type
Ultrasound
Scanner
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
Tablet PC or
Mobile Phone
which supports
by iOS,
Android OS or
Windows
System.	Wireless Probe
Type
Ultrasound
Scanner
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
Tablet PC or
Mobile Phone
which supports
by iOS,
Android OS or
Windows
System.	Wireless Probe
Type
Ultrasound
Scanner
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
Tablet PC or
Mobile Phone
which supports
by iOS,
Android OS or
Windows
System.	Wireless Probe
Type
Ultrasound
Scanner
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
Tablet PC or
Mobile Phone
which supports
by iOS,
Android OS or
Windows
System.	Wireless Probe
Type
Ultrasound
Scanner
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
Tablet PC or
Mobile Phone
which supports
by iOS,
Android OS or
Windows
System.	iOS mobile
device	SONON
Ultrasound
Imaging System
battery-
operated, hand-
held ultrasound
diagnostic
transducer that
communicates
wirelessly with
iOS or Android
mobile device
Patient
Contacting
Materials	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Patient contact
materials are
biocompatible.	Evaluated
according to
FDA
recognized
standards - ISO	All materials
with patient
contact are
biocompatible
and can be	All materials with
patient contact
are biocompatible
and can be
disinfected
Comparison
Items	Subject Device					Predicate Device
						10993-5 and
ISO 10993-10	disinfected
Electrical
Safety	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to
IEC 60601-1	Evaluated
according to IEC
60601-1
EMC	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to
IEC 60601-1-2	Evaluated
according to IEC
60601-1-2
Performance
Safety	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to
IEC 60601-2-37	Evaluated
according to IEC
60601-2-37

10

Image /page/10/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned to the left of the word, creating a visually appealing and recognizable brand identity.

11

Image /page/11/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a sans-serif font. The butterfly is a light blue color and appears to be in flight. The word "bionet" is in a darker shade of blue.

12

Image /page/12/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word "bionet" is a stylized image of a butterfly with a light blue color. The butterfly is positioned so that it appears to be flying above the text.

13

Image /page/13/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned above and slightly to the left of the word "bionet."

14

Image /page/14/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in lowercase, sans-serif font, with the "b" in black and the rest of the letters in a slightly lighter shade of black. Above the word "bionet" is a stylized image of a butterfly wing in a light blue color. The wing is positioned diagonally, giving the logo a sense of movement and lightness.

*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler

Model: H5C10L

| Comparison

Items	Subject Device		Predicate Device
Device Name /
Model Name	Wireless Probe Type
Ultrasound Scanner /
Model: H5C10L
(Under Review)	Wireless Probe Type
Ultrasound Scanner /
Model: UProbe-C
(K172750)	SONON Ultrasound
Imaging System /
Model: SONON 300C
(K151339)	Wireless Probe Type
Ultrasound Scanner /
Model: UProbe-L
(K172750)	SONON Ultrasound
Imaging System /
Model: SONON 300L
(K170085)	C5 Diagnostic
Ultrasound System
(K171926)
Manufacturer	Bionet Co., Ltd.	Guangzhou Sonostar
Technologies Co.,
Ltd.	Healcerion Co., Ltd.	Guangzhou Sonostar
Technologies Co.,
Ltd.	Healcerion Co., Ltd.	Guangzhou Sonostar
Technologies Co.,
Ltd.
Product Code	IYN, IYO, ITX	IYO, ITX	IYO, ITX	IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX
Classification	Class 2	Class 2	Class 2	Class 2	Class 2	Class 2
Indication for
Use	SonoMe is indicated
for examining the
adult, pregnant
woman, and children.
This products is
intended for use by, or
by the order of, and
under the supervision
of, a licensed
physician who is
qualified for direct use
of medical devices. An	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including obstetrics
(OB), gynecology
(GYN) and general
(abdominal) imaging.	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including obstetrics
(OB), gynecology
(GYN) and general
(abdominal) imaging.	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including small organ
and peripheral vessel
imaging.	Intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general
clinical applications
including
musculoskeletal
(MSK), vascular,
small parts (breast,
thyroid), and	C5 Diagnostic
Ultrasound System is
a general-purpose
ultrasonic imaging
instrument intended
for use by a qualified
physician for
evaluation for Fetal,
Abdominal, Pediatric,
Small Organ (breast,
testes, thyroid), Trans-
vaginal, Peripheral
Comparison
Items	Subject Device	Predicate Device
	appropriately trained
healthcare
professionals can have
operator
qualifications. The
device use settings are
intended in hospital
clinic, and medical
office settings. The
general clinical
applications include
fetal/obstetrics(OB),
gynecology(GYN),
abdominal, small
organ and peripheral
vessel imaging.
The modes of
operation are B-mode,
PDI(Power Doppler
Imaging) mode,
PW(Pulse Wave
Spectral Doppler)
mode and Harmonic
mode.
Environment
of Use	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings	Hospital, clinic, and
medical office settings
Acoustic
Output Levels	Track 3	Track 3	Track 3	Track 3	Track 3	Track 3
Display mode	B, B/M, Color, *PDI,
**PW	B, B/M	B	B, B/M	B, Color	B, M, **PW, Color,
*PDI, Compound
Imaging
Patient
Population	For use in all patients	For use in all patients	For use in all patients	For use in all patients	For use in all patients	For use in all patients
Clinical
application	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal, small	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	General clinical
applications, including
small organ and
peripheral vessel
imaging	General clinical
applications, including
fetal/obstetrics,
gynecology,
abdominal	Fetal, Abdominal,
Pediatric, Small Organ
(breast, testes,
thyroid), Trans-
vaginal, Peripheral
		thoracic/pleural
motion and fluid
detection imaging.	Vascular, Musculo-
skeletal (Conventional
and Superficial),
Cardiac (neonatal and
adult), OB/Gyn and
Urology.
Comparison
Items	Subject Device			Predicate Device
	organ and peripheral
vessel imaging.					Vascular, Musculo-
skeletal (Conventional
and Superficial),
Cardiac (neonatal and
adult), OB/Gyn and
Urology.
Users	Healthcare
professionals	Healthcare
professionals	Healthcare
professionals	Healthcare
professionals	Healthcare
professionals	Healthcare
professionals
Principle
Method
of
Operation	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves
are reflected back to
the transducer and
converted to electrical
signals that are
processed and
displayed as image of
anatomic structures.	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves
are reflected back to
the transducer and
converted to electrical
signals that are
processed and
displayed as image of
anatomic structures.	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves
are reflected back to
the transducer and
converted to electrical
signals that are
processed and
displayed as image of
anatomic structures.	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves
are reflected back to
the transducer and
converted to electrical
signals that are
processed and
displayed as image of
anatomic structures.	Piezoelectric material
in the transducer is
used as an ultrasound
source to transmit
sound waves into the
body. Sound waves
are reflected back to
the transducer and
converted to electrical
signals that are
processed and
displayed as image of
anatomic structures.	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.
Image Display
Unit	Mobile device (4 to 13
inches approximately)	Mobile device (4 to 13
inches approximately)	Mobile device (4 to 10
inches approximately)	Mobile device (4 to 13
inches approximately)	Mobile device (4 to 10
inches approximately)	15 inch LCD monitor
Probe
Characteristics	Convex: 3.2MHz /
5MHz
Linear: 7.5MHz/
10MHz	Convex: 3.5MHz
frequency	Convex, 3.5MHz
frequency	Linear, 7.5MHz
frequency	Linear, 5/7.5/10MHz
frequency	Supporting Linear
probes (7.5MHz &
6.5MHz) and Convex
array probes (3.5MHz
& 5.0MHz)
Probe
Connection to
Display	Wireless	Wireless	Wireless	Wireless	Wireless	Non Wireless
Operation
System	iOS / Android /
Windows	iOS	iOS / Android	iOS	iOS / Android	Linux
Software	Run as an app on off-
the-shelf mobile
device	Run as an app on off-
the-shelf mobile
device	Run as an app on off-
the-shelf mobile
device	Run as an app on off-
the-shelf mobile
device	Run as an app on off-
the-shelf mobile
device	Based on an
embedded Linux
Operating System
System
Components	Commercial off-the-
shelf iOS mobile	Commercial off-the-
shelf iOS mobile	Commercial off-the-
shelf iOS or Android	Commercial off-the-
shelf iOS mobile	Commercial off-the-
shelf iOS or Android	The C5 Diagnostic
Ultrasound System is
Comparison
Items	Subject Device	Predicate Device
	device
Wireless Probe Type
Ultrasound Scanner
software that runs as
an app on the mobile
device
Wireless Probe Type
Ultrasound Scanner
battery-operated,
hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with Tablet
PC or Mobile Phone
which supports by
iOS, Android OS or
Windows System.	device
Wireless Probe Type
Ultrasound Scanner
software that runs as
an app on the mobile
device
Wireless Probe Type
Ultrasound Scanner
battery-operated,
hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with iOS
mobile device	mobile device
SONON Ultrasound
Imaging System
software that runs as
an app on the mobile
device
SONON Ultrasound
Imaging System
battery-operated,
hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with iOS or
Android mobile
device	device
Wireless Probe Type
Ultrasound Scanner
software that runs as
an app on the mobile
device
Wireless Probe Type
Ultrasound Scanner
battery-operated,
hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with iOS
mobile device	mobile device
SONON Ultrasound
Imaging System
software that runs as
an app on the mobile
device
SONON Ultrasound
Imaging System
battery-operated,
hand-held ultrasound
diagnostic transducer
that communicates
wirelessly with iOS or
Android mobile
device	an integrated
preprogrammed
color ultrasound
imaging system,
capable of producing
high detail
resolution intended for
clinical diagnostic
imaging system.
Patient
Contacting
Materials	Patient contact
materials are
biocompatible.	Evaluated according
to FDA recognized
standards - ISO
10993-5 and ISO
10993-10	All materials with
patient contact are
biocompatible and can
be disinfected	Evaluated according
to FDA recognized
standards - ISO
10993-5 and ISO
10993-10	All materials with
patient contact are
biocompatible and can
be disinfected	All materials with
patient contact are
biocompatible and can
be disinfected
Electrical	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according
Safety	to IEC 60601-1	to IEC 60601-1	to IEC 60601-1	to IEC 60601-1	to IEC 60601-1	to IEC 60601-1
EMC	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according
	to IEC 60601-1-2	to IEC 60601-1-2	to IEC 60601-1-2	to IEC 60601-1-2	to IEC 60601-1-2	to IEC 60601-1-2
Performance	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according	Evaluated according
Safety	to IEC 60601-2-37	to IEC 60601-2-37	to IEC 60601-2-37	to IEC 60601-2-37	to IEC 60601-2-37	to IEC 60601-2-37

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Image /page/15/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a lowercase, sans-serif font. Above the word "bionet" is a stylized butterfly icon in a light blue color. The butterfly is positioned above and slightly to the right of the word "bionet".

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Image /page/16/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a lowercase, sans-serif font. The butterfly is positioned to the left of the word, creating a visually appealing and recognizable brand identity.

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Image /page/17/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in lowercase, black, sans-serif font. The butterfly is positioned to the left of the word, creating a simple and clean design. The overall impression is modern and professional.

*PDI: Power Doppler Imaging, **PW: Pulse Wave Spectral Doppler

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8. Summary of Non-Clinical Test

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

IEC 60601-1:2005. AMD1:2012 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance

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

IEC 60601-2-37: 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity

ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 14971: 2007 Medical devices - Application of risk management to medical devices

IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62366-1: 2015 Medical devices - Part 1: Application of usability engineering to medical devices

ISO15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling. and information to be supplied - Part 1: General requirements

9. Summary of Clinical Tests

The subject of this premarket submission, SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25), did not require clinical studies to support substantial equivalence.

10. Conclusion

Bionet Co., Ltd. considers the SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) to be as safe, as effective, and performance is substantially equivalent to the predicate device.