FLAT PANEL DETECTOR, MODEL FDR D-EVO

FLAT PANEL DETECTOR, MODEL FDR D-EVO is an FDA 510(k)-cleared medical device (K100762) manufactured by Fujifilm Medical Systems 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 July 14, 2010. Regulation: 8.