Clearance Summary
P-Cure Proton Therapy System (PPTS) received FDA 510(k) clearance under submission number K242418, sponsored by P-Cure, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-05-12.
- Submission: K242418
- Applicant / Sponsor: P-Cure, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2025-05-12
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.