Discovery MI Gen2 is an AI-enabled medical device from GE Medical Systems, LLC., listed by FDA (510(k), K211846) with a decision date of 2021-08-20. Review panel: Radiology.
| FDA submission number | K211846 |
|---|---|
| Pathway | 510(k) |
| Company | GE Medical Systems, LLC. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-08-20 |
| Decision | Substantially Equivalent |
| Product code | KPS |
| Classification | System, Tomography, Computed, Emission |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 66 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.