IBA PROTON THERAPY SYSTEM- PROTEUS 235

IBA PROTON THERAPY SYSTEM- PROTEUS 235 is an FDA 510(k)-cleared medical device (K082416) manufactured by Ion Beam Applications S.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 2008. Regulation: 8.