FDR D-EVO II FLAT PANEL DETECTOR SYSTEM

FDR D-EVO II FLAT PANEL DETECTOR SYSTEM is an FDA 510(k)-cleared medical device (K142003) manufactured by Fujifilm Medical System U.S.A., 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 20, 2014. Regulation: 8.