CT 8000 DIGITAL INJECTION SYSTEM

CT 8000 DIGITAL INJECTION SYSTEM is an FDA 510(k)-cleared medical device (K912944) manufactured by Mallinckrodt Group, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 1992. Regulation: 8.