True Definition DL is an AI-enabled medical device from Ge Healthcare Japan Corporation, listed by FDA (510(k), K253686) with a decision date of 2026-03-23. Review panel: Radiology.
| FDA submission number | K253686 |
|---|---|
| Pathway | 510(k) |
| Company | Ge Healthcare Japan Corporation |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-03-23 |
| Decision | Substantially Equivalent |
| Product code | JAK |
| Classification | System, X-Ray, Tomography, Computed |
| Device class | 2 |
| Regulation number | 892.1750 |
| Review time (calendar days) | 122 |
| Applicant country | JP |
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.