SCENARIA WHOLE-BODY X-RAY CT SYSTEM

SCENARIA WHOLE-BODY X-RAY CT SYSTEM is an FDA 510(k)-cleared medical device (K101888) manufactured by Hitachi Medical Systems America, 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 7, 2011. Regulation: 8.