SYNERAD OMNI, MODELS AN6255 AND AN6265

SYNERAD OMNI, MODELS AN6255 AND AN6265 is an FDA 510(k)-cleared medical device (K071430) manufactured by Analogic Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2007. Regulation: 8.