QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) is an FDA 510(k)-cleared medical device (K993763) manufactured by Medis Medical Imaging Systems BV. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 1999. Regulation: 8.