MRI Planner is an AI-enabled medical device from Spectronic Medical AB, listed by FDA (510(k), K211841) with a decision date of 2022-08-25. Review panel: Radiology.
| FDA submission number | K211841 |
|---|---|
| Pathway | 510(k) |
| Company | Spectronic Medical AB |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-08-25 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 437 |
| Applicant country | SE |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.