ISOCENTRIC NEUTRON THERAPY SYSTEMS

ISOCENTRIC NEUTRON THERAPY SYSTEMS is an FDA 510(k)-cleared medical device (K812337) manufactured by The Cyclotron Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 1981. Regulation: 8.