510(k) K201059

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System by Sonoscape Medical Corp. — Product Code IYN

K201059 is an FDA 510(k) premarket notification submitted by Sonoscape Medical Corp. for the device "S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System". The FDA issued a decision of Substantially Equivalent on July 30, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Sonoscape Medical Corp. has at least 10 other 510(k) clearances on record.