ART-Plan+ (v.3.0.0) is an AI-enabled medical device from Therapanacea SAS, listed by FDA (510(k), K242822) with a decision date of 2025-02-25. Review panel: Radiology.
| FDA submission number | K242822 |
|---|---|
| Pathway | 510(k) |
| Company | Therapanacea SAS |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-02-25 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 160 |
| Applicant country | FR |
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.