SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Q: Who is the manufacturer of SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

Bionet Co., Ltd. filed the 510(k) submission for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (K220169).

Q: What is the FDA product code for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

UProbe-C (K172750); SONON 300C (K151339); C5 Diagnostic Ultrasound System (K171926); UProbe-L (K172750); SONON 300L (K170085).

Q: Who can help prepare an FDA 510(k) submission like SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K220169 · Bionet Co., Ltd. · IYN · Oct 11, 2022 · Radiology

Device Facts

Record ID	K220169
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)
Applicant	Bionet Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Oct 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Wireless ultrasound system using pulsed-echo technology; consists of battery-operated hand-held transducer and software app running on commercial off-the-shelf (COTS) iOS, Android, or Windows mobile devices/tablets. Transducer transmits ultrasound waves into body; reflected echoes converted to electrical signals; processed and displayed as anatomical images on mobile device screen. Used in hospital, clinic, and medical office settings by physicians or trained healthcare professionals. Provides diagnostic imaging to assist in clinical decision-making for fetal, OB/GYN, abdominal, small organ, and vascular applications. Benefits include portability and wireless connectivity for diagnostic ultrasound imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, electrical, and mechanical safety standards.

Technological Characteristics

Hand-held wireless ultrasound transducer using piezoelectric material. Modes: B-mode, PDI, PW Doppler, Harmonic. Connectivity: Wireless to COTS mobile devices (iOS, Android, Windows). Biocompatible patient-contact materials. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1/5/10.

Indications for Use

Indicated for adult, pregnant, and pediatric patients. Used for fetal/OB, GYN, abdominal, small organ, and peripheral vessel imaging. Intended for use by or under supervision of licensed physicians or trained healthcare professionals in hospital, clinic, and medical office settings.

Regulatory Classification

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.

Predicate Devices

UProbe-C (K172750)
SONON 300C (K151339)
C5 Diagnostic Ultrasound System (K171926)
UProbe-L (K172750)
SONON 300L (K170085)

Related Devices

K211321 — Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) · Guangzhou Sonostar Technologies Co., Ltd. · Oct 13, 2022
K211665 — SONON Ultrasound Imaging System, Model: SONON300C · Healcerion Co., Ltd. · May 16, 2022
K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series) · Leltek, Inc. · Oct 25, 2022
K191541 — Vave Personal Ultrasound System · Vave Health, Inc. · Jul 10, 2019
K250791 — ASUS Ultrasound Imaging System (LU800 series) · Asustek Computer, Inc. · Dec 4, 2025

Submission Summary (Full Text)

{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) #### 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 PRAStaff(@fda.hhs.gov "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." {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 | |…