K252815
- 510(k) number
- K252815
- Device name
- ProBeam 360 Proton Therapy System v3.0
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2026-04-23
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252815.pdf
Official FDA record: K252815
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.