ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)

ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM) is an FDA 510(k)-cleared medical device (K897115) 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 12, 1990. Regulation: 8.