510(k) K242418

P-Cure Proton Therapy System (PPTS) by P-Cure, Ltd. — Product Code LHN

K242418 is an FDA 510(k) premarket notification submitted by P-Cure, Ltd. for the device "P-Cure Proton Therapy System (PPTS)". The FDA issued a decision of Substantially Equivalent on May 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. P-Cure, Ltd. has at least 3 other 510(k) clearances on record.