Fibresolve (with PCCP) is an AI-enabled medical device from Imvaria, Inc., listed by FDA (510(k), K252041) with a decision date of 2025-11-07. Review panel: Radiology.
| FDA submission number | K252041 |
|---|---|
| Pathway | 510(k) |
| Company | Imvaria, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-11-07 |
| 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) | 130 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Imvaria, Inc. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.