# K220169: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Oct 11, 2022 after 264 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 224 ancestors in all.
No later device cites it as a predicate yet.
6 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe), Guangzhou Sonostar Technologies Co., Ltd. (2018) Summary page 5.
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C), Healcerion Co., Ltd. (2015) Summary page 5.
- K171926: C5 Diagnostic Ultrasound System, Guangzhou Sonostar Technologies Co., Ltd. (2017) Summary page 5.
- K170085: SONON Ultrasound Imaging System, Model: 300L, Healcerion Co., Ltd. (2017) Summary page 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 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.

Source page: https://510kreport.com/device/K220169
Methodology: https://510kreport.com/methodology