TSX-002A (XVISION) CT SCANNER

TSX-002A (XVISION) CT SCANNER is an FDA 510(k)-cleared medical device (K941745) 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 July 28, 1994. Regulation: 8.