AUKLET CT SCANNER, TSX-003A

AUKLET CT SCANNER, TSX-003A is an FDA 510(k)-cleared medical device (K973908) 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 December 21, 1997. Regulation: 8.