510(k) K083058

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

K083058 is an FDA 510(k) premarket notification submitted by Ion Beam Applications S.A. for the device "IBA PROTON THERAPY SYSTEM - PROTEUS 235". The FDA issued a decision of Substantially Equivalent on April 15, 2009. 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.