RadOncAI is an AI-enabled medical device from Informai, listed by FDA (510(k), K253050) with a decision date of 2026-06-18. Review panel: Radiology.
| FDA submission number | K253050 |
|---|---|
| Pathway | 510(k) |
| Company | Informai |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-06-18 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 269 |
| Applicant country | US |
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.