510(k) K112022

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM by Advanced Instrumentations, Inc. — Product Code IYO

K112022 is an FDA 510(k) premarket notification submitted by Advanced Instrumentations, Inc. for the device "DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 22, 2011. 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.