Monaco RTP System (6.3) is an AI-enabled medical device from Elekta Solutions AB, listed by FDA (510(k), K252002) with a decision date of 2026-02-19. Review panel: Radiology.
| FDA submission number | K252002 |
|---|---|
| Pathway | 510(k) |
| Company | Elekta Solutions AB |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-02-19 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 237 |
| Applicant country | SE |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.