TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM

TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K896456) manufactured by Toshiba America Medical Systems, In.C. 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 7, 1990. Regulation: 8.