DeepXray Spina is an AI-enabled medical device from Alpha Intelligence Manifolds, Inc., listed by FDA (510(k), K253192) with a decision date of 2026-06-10. Review panel: Radiology.
| FDA submission number | K253192 |
|---|---|
| Pathway | 510(k) |
| Company | Alpha Intelligence Manifolds, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-06-10 |
| Decision | Substantially Equivalent |
| Product code | SAO |
| Classification | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device class | 2 |
| Regulation number | 892.1171 |
| Review time (calendar days) | 257 |
| Applicant country | TW |
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.