SIGNA Hero is an AI-enabled medical device from GE Healthcare (GE Medical Systems, LLC), listed by FDA (510(k), K213668) with a decision date of 2022-01-20. Review panel: Radiology.
| FDA submission number | K213668 |
|---|---|
| Pathway | 510(k) |
| Company | GE Healthcare (GE Medical Systems, LLC) |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-01-20 |
| Decision | Substantially Equivalent |
| Product code | LNH |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Device class | 2 |
| Regulation number | 892.1000 |
| Review time (calendar days) | 59 |
| Applicant country | US |
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.