510(k) K102023

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C by Shantou Institute Of Ultrasonic Instruments (Siui — Product Code IYN

K102023 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments (Siui for the device "DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C". The FDA issued a decision of Substantially Equivalent on Oct 19, 2010. 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.