510(k) K221089

P12 Elite Series Digital Color Doppler Ultrasound System by Sonoscape Medical Corp. — Product Code IYN

K221089 is an FDA 510(k) premarket notification submitted by Sonoscape Medical Corp. for the device "P12 Elite Series Digital Color Doppler Ultrasound System". The FDA issued a decision of Substantially Equivalent on September 15, 2022. 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.