510(k) K890998

QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. by Quantum Medical Systems, Inc. — Product Code IYN

K890998 is an FDA 510(k) premarket notification submitted by Quantum Medical Systems, Inc. for the device "QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.". The FDA issued a decision of Substantially Equivalent on May 2, 1989. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Quantum Medical Systems, Inc. has at least 4 other 510(k) clearances on record.