510(k) K254297 ยท SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Tempus ECG-MR
| Applicant | Tempus AI, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254297
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.