FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE is an FDA 510(k)-cleared medical device (K924012) 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 15, 1992. Regulation: 8.