RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM is an FDA 510(k)-cleared medical device (K981346) manufactured by Surgical Navigation Technologies, 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 July 9, 1998. Regulation: 8.