510(k) K220983

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System by Imsonic Medical China, Inc. — Product Code IYN

K220983 is an FDA 510(k) premarket notification submitted by Imsonic Medical China, Inc. for the device "ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System". The FDA issued a decision of Substantially Equivalent on Nov 11, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.