Supria True64 Whole-Body X-Ray CT System

Supria True64 Whole-Body X-Ray CT System is an FDA 510(k)-cleared medical device (K183291) manufactured by Hitachi Healthcare Americas. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2019. Regulation: 8.