FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK

FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK is an FDA 510(k)-cleared medical device (K921112) 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 April 26, 1993. Regulation: 8.