V5med Lung AI is an AI-enabled medical device from V5med Inc., listed by FDA (510(k), K242919) with a decision date of 2025-03-27. Review panel: Radiology.
| FDA submission number | K242919 |
|---|---|
| Pathway | 510(k) |
| Company | V5med Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-03-27 |
| Decision | Substantially Equivalent |
| Product code | OEB |
| Classification | Lung Computed Tomography System, Computer-Aided Detection |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 184 |
| Applicant country | TW |
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.