510(k) K250986

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) by Mevion Medical Systems, Inc. — Product Code LHN

K250986 is an FDA 510(k) premarket notification submitted by Mevion Medical Systems, Inc. for the device "S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)". The FDA issued a decision of Substantially Equivalent on September 12, 2025. 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, Inc. has at least 3 other 510(k) clearances on record.