K231863
- 510(k) number
- K231863
- Device name
- ProBeam 360° Proton Therapy System v2.0 (Multiroom)
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2023-10-06
- Date received
- 2023-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231863.pdf
Official FDA record: K231863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.