510(k) K993763

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) by Medis Medical Imaging Systems BV — Product Code IZI

K993763 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)". The FDA issued a decision of Substantially Equivalent on November 26, 1999. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.