CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS

CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS is an FDA 510(k)-cleared medical device (K982004) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 1998. Regulation: 8.