ART-Plan is an AI-enabled medical device from TheraPanacea, listed by FDA (510(k), K232479) with a decision date of 2023-12-22. Review panel: Radiology.
| FDA submission number | K232479 |
|---|---|
| Pathway | 510(k) |
| Company | TheraPanacea |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-12-22 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 128 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
More devices from TheraPanacea · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.