FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM

FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K121499) 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 November 19, 2012. Regulation: 8.