510(k) K191521

Radiance 330 Proton Beam Therapy System by Protom International Holding Corporation — Product Code LHN

K191521 is an FDA 510(k) premarket notification submitted by Protom International Holding Corporation for the device "Radiance 330 Proton Beam Therapy System". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.