WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE

WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE is an FDA 510(k)-cleared medical device (K111865) 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 29, 2011. Regulation: 8.