510(k) 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) by Bionet Co., Ltd. — Product Code IYN

K220169 is an FDA 510(k) premarket notification submitted by Bionet Co., Ltd. for the device "SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)". The FDA issued a decision of Substantially Equivalent on October 11, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Bionet Co., Ltd. has at least 10 other 510(k) clearances on record.