RayStation 10.1 is an AI-enabled medical device from RaySearch Laboratories AB (publ), listed by FDA (510(k), K210645) with a decision date of 2021-06-29. Review panel: Radiology.
| FDA submission number | K210645 |
|---|---|
| Pathway | 510(k) |
| Company | RaySearch Laboratories AB (publ) |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-06-29 |
| Decision | Substantially Equivalent |
| Product code | MUJ |
| Classification | System, Planning, Radiation Therapy Treatment |
| Device class | 2 |
| Regulation number | 892.5050 |
| Review time (calendar days) | 118 |
| Applicant country | SE |
Official FDA database record · FDA AI-enabled device list
More devices from RaySearch Laboratories AB (publ) · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.