SCENARIA Phase 3 Whole-body X-ray CT System

SCENARIA Phase 3 Whole-body X-ray CT System is an FDA 510(k)-cleared medical device (K150595) 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 October 29, 2015. Regulation: 8.