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)
(FDA 510(k) Clearance)

K220169 is an FDA 510(k) clearance for 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), a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Bionet Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 11, 2022, 264 days after receiving the submission on January 20, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.