RADIANCE 330 PROTON THERAPY SYSTEM

RADIANCE 330 PROTON THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K134052) manufactured by Protom International, 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 March 13, 2014. Regulation: 8.