FDR D-EVO GL Flat Panel Detector System

FDR D-EVO GL Flat Panel Detector System is an FDA 510(k)-cleared medical device (K152138) 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 November 4, 2015. Regulation: 8.