
Ion Beam Applications S.A.
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IBA PROTON THERAPY SYSTEM - PROTEUS 235 is an FDA 510(k)-cleared medical device (K083058) 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 April 14, 2009. Regulation: 8.