K242418
- 510(k) number
- K242418
- Device name
- P-Cure Proton Therapy System (PPTS)
- Applicant
- P-Cure, Ltd. IL
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2025-05-12
- Date received
- 2024-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242418.pdf
Official FDA record: K242418
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.