510(k) K120676

S-250 PROTON BEAM RADIATION THERAPY SYSTEM by Mevion Medical Systems — Product Code LHN

K120676 is an FDA 510(k) premarket notification submitted by Mevion Medical Systems for the device "S-250 PROTON BEAM RADIATION THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 4, 2012. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Mevion Medical Systems has at least 3 other 510(k) clearances on record.