K250963
- 510(k) number
- K250963
- Device name
- PlanOne 1
- Applicant
- Cosylab Jsc, Control System Laboratory SI
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-11-20
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250963.pdf
Official FDA record: K250963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.