IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM

IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM is an FDA 510(k)-cleared medical device (K972229) manufactured by Heartware, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1997. Regulation: 8.