510(k) K853217

QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES by Quantum Medical Systems, Inc. — Product Code IYO

K853217 is an FDA 510(k) premarket notification submitted by Quantum Medical Systems, Inc. for the device "QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES". The FDA issued a decision of Substantially Equivalent on December 30, 1985. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Quantum Medical Systems, Inc. has at least 4 other 510(k) clearances on record.