510(k) K121867

SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS by Chison Medical Imaging Co., Ltd. — Product Code IYN

K121867 is an FDA 510(k) premarket notification submitted by Chison Medical Imaging Co., Ltd. for the device "SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS". The FDA issued a decision of Substantially Equivalent on Aug 2, 2012. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Chison Medical Imaging Co., Ltd. has 12 other 510(k) clearances on record.