510(k) K101508

MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 by Ion Beam Applications S.A. — Product Code LHN

K101508 is an FDA 510(k) premarket notification submitted by Ion Beam Applications S.A. for the device "MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235". The FDA issued a decision of Substantially Equivalent on August 6, 2010. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Ion Beam Applications S.A. has at least 10 other 510(k) clearances on record.