Omni Legend is an AI-enabled medical device from GE Medical Systems Israel, Functional Imaging, listed by FDA (510(k), K241665) with a decision date of 2024-08-08. Review panel: Radiology.
| FDA submission number | K241665 |
|---|---|
| Pathway | 510(k) |
| Company | GE Medical Systems Israel, Functional Imaging |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-08-08 |
| Decision | Substantially Equivalent |
| Product code | KPS |
| Classification | System, Tomography, Computed, Emission |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 59 |
| Applicant country | IL |
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.