510(k) K160283

S45 Digital Color Doppler Ultrasound System by Sonoscape Medical Corp. — Product Code IYN

K160283 is an FDA 510(k) premarket notification submitted by Sonoscape Medical Corp. for the device "S45 Digital Color Doppler Ultrasound System". The FDA issued a decision of Substantially Equivalent on April 4, 2016. 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.