510(k) K221791

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

K221791 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "ProBeam 360° Proton Therapy System". The FDA issued a decision of Substantially Equivalent on December 1, 2022. 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.