Radiation Planning Assistant (RPA) is an AI-enabled medical device from University of Texas, MD Anderson Cancer Center, listed by FDA (510(k), K222728) with a decision date of 2023-05-17. Review panel: Radiology.
| FDA submission number | K222728 |
|---|---|
| Pathway | 510(k) |
| Company | University of Texas, MD Anderson Cancer Center |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-05-17 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 251 |
| 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.