Galen™ Second Read™ is an AI-enabled medical device from Ibex Medical Analytics Ltd., listed by FDA (510(k), K241232) with a decision date of 2025-01-24. Review panel: Pathology.
| FDA submission number | K241232 |
|---|---|
| Pathway | 510(k) |
| Company | Ibex Medical Analytics Ltd. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2025-01-24 |
| Decision | Substantially Equivalent |
| Product code | QPN |
| Classification | Software Algorithm Device To Assist Users In Digital Pathology |
| Device class | 2 |
| Regulation number | 864.3750 |
| Review time (calendar days) | 267 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Pathology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.