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Accuray, Inc.
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CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY is an FDA 510(k)-cleared medical device (K032345) manufactured by Accuray, 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 September 2, 2003. Regulation: 8.