HITACHI Supria Whole-body X-ray CT System Phase 3

HITACHI Supria Whole-body X-ray CT System Phase 3 is an FDA 510(k)-cleared medical device (K163528) 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 March 2, 2017. Regulation: 8.