FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ is an FDA 510(k)-cleared medical device (K951373) 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 26, 1995. Regulation: 8.