Dose+ (1.0)
510(k)K250064RadiologyMUJ
Mvision AI Oy is listed for Dose+ (1.0) (K250064). The FDA list gives September 4, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MUJ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250064
- Date of final decision
- September 4, 2025
- Company on the FDA list
- Mvision AI Oy
- Lead panel
- Radiology
- Primary product code
- MUJ
- openFDA device name for the code
- System, Planning, Radiation Therapy Treatment
- Device class
- 2
- Regulation number
- 892.5050
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary