510(k) K101008

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY by Shantou Institute Of Ultrasonic Instruments (Siui — Product Code ITX

K101008 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments (Siui for the device "DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY". The FDA issued a decision of Substantially Equivalent on Jun 8, 2010. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Shantou Institute Of Ultrasonic Instruments (Siui has at least 4 other 510(k) clearances on record.