DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY is an FDA 510(k)-cleared medical device (K101008) manufactured by Shantou Institute of Ultrasonic Instruments (Siui. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2010. Regulation: 8.