510(k) K221996

P-Cure Proton Beam Therapy System by P-Cure, Ltd. — Product Code LHN

K221996 is an FDA 510(k) premarket notification submitted by P-Cure, Ltd. for the device "P-Cure Proton Beam Therapy System". The FDA issued a decision of Substantially Equivalent on March 20, 2023. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. P-Cure, Ltd. has at least 3 other 510(k) clearances on record.