510(k) K172848

MEVION S250i Proton Beam Radiation Therapy Device by Mevion Medical Systems — Product Code LHN

K172848 is an FDA 510(k) premarket notification submitted by Mevion Medical Systems for the device "MEVION S250i Proton Beam Radiation Therapy Device". The FDA issued a decision of Substantially Equivalent on December 27, 2017. 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.