K250064
- 510(k) number
- K250064
- Device name
- Dose+ (1.0)
- Applicant
- Mvision AI OY FI
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-09-04
- Date received
- 2025-01-10
- 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: K250064.pdf
Official FDA record: K250064
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.