510(k) K140364

CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE by Chison Medical Imaging Co., Ltd. — Product Code IYN

K140364 is an FDA 510(k) premarket notification submitted by Chison Medical Imaging Co., Ltd. for the device "CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE". The FDA issued a decision of Substantially Equivalent on Jun 2, 2014. 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.