OncoStudio (OS-01) is an AI-enabled medical device from OncoSoft. Co., Ltd., listed by FDA (510(k), K242994) with a decision date of 2025-02-24. Review panel: Radiology.
| FDA submission number | K242994 |
|---|---|
| Pathway | 510(k) |
| Company | OncoSoft. Co., Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-02-24 |
| Decision | Substantially Equivalent |
| Product code | QKB |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 151 |
| Applicant country | KR |
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.