510(k) K172055

DUS-7000 Digital Color Doppler Ultrasound System by Advanced Instrumentations, Inc. — Product Code IYN

K172055 is an FDA 510(k) premarket notification submitted by Advanced Instrumentations, Inc. for the device "DUS-7000 Digital Color Doppler Ultrasound System". The FDA issued a decision of Substantially Equivalent on August 31, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Advanced Instrumentations, Inc. has at least 10 other 510(k) clearances on record.