RTR-2000/RTR-4000

RTR-2000/RTR-4000 is an FDA 510(k)-cleared medical device (K974307) manufactured by Terarecon,Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 1998. Regulation: 8.