CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2

CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 is an FDA 510(k)-cleared medical device (K053062) manufactured by Cardiarc , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2006. Regulation: 8.