FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR is an FDA 510(k)-cleared medical device (K952862) 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 September 19, 1995. Regulation: 8.