ANGIOREX CAT-350B

ANGIOREX CAT-350B is an FDA 510(k)-cleared medical device (K951053) 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 April 5, 1995. Regulation: 8.