BIOGRAPH One is an AI-enabled medical device from Siemens Healthineers AG, listed by FDA (510(k), K253023) with a decision date of 2026-01-15. Review panel: Radiology.
| FDA submission number | K253023 |
|---|---|
| Pathway | 510(k) |
| Company | Siemens Healthineers AG |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-01-15 |
| Decision | Substantially Equivalent |
| Product code | OUO |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 118 |
| Applicant country | DE |
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.