CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM is an FDA 510(k)-cleared medical device (K062514) manufactured by Accuray Incorporated. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2006. Regulation: 8.