Clearance Summary
P-Cure Proton Beam Therapy System received FDA 510(k) clearance under submission number K221996, 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 2023-03-20.
- Submission: K221996
- Applicant / Sponsor: P-Cure, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2023-03-20
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.