510(k) K172931

DUS-6000 Digital Ultrasonic Diagnostic Imaging System by Advanced Instrumentations, Inc. — Product Code IYO

K172931 is an FDA 510(k) premarket notification submitted by Advanced Instrumentations, Inc. for the device "DUS-6000 Digital Ultrasonic Diagnostic Imaging System". The FDA issued a decision of Substantially Equivalent on December 1, 2017. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Advanced Instrumentations, Inc. has at least 10 other 510(k) clearances on record.