510(k) K103144

DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER by Shantou Institute Of Ultrasonic Instruments (Siui — Product Code IYN

K103144 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments (Siui for the device "DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER". The FDA issued a decision of Substantially Equivalent on Jan 12, 2011. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Shantou Institute Of Ultrasonic Instruments (Siui has at least 4 other 510(k) clearances on record.