510(k) K253192 ยท SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
DeepXray Spina
| Applicant | Alpha Intelligence Manifolds, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253192
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.