
Proton Systems
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PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR is an FDA 510(k)-cleared medical device (K121657) manufactured by Proton Systems. 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 22, 2012. Regulation: 8.