510(k) K252815

ProBeam 360 Proton Therapy System v3.0 by Varian Medical Systems, Inc. — Product Code LHN

K252815 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "ProBeam 360 Proton Therapy System v3.0". The FDA issued a decision of Substantially Equivalent on April 23, 2026. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.