IBA PROTON THERAPY SYSTEM - PROTEUS 235

IBA PROTON THERAPY SYSTEM - PROTEUS 235 is an FDA 510(k)-cleared medical device (K061913) 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 July 27, 2006. Regulation: 8.