ScreenDx is an AI-enabled medical device from Imvaria, Inc, listed by FDA (510(k), K241891) with a decision date of 2025-01-10. Review panel: Radiology.
| FDA submission number | K241891 |
|---|---|
| Pathway | 510(k) |
| Company | Imvaria, Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-01-10 |
| Decision | Substantially Equivalent |
| Product code | QWO |
| Classification | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. |
| Device class | 2 |
| Regulation number | 892.2085 |
| Review time (calendar days) | 196 |
| Applicant country | US |
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.