510(k) K250652 ยท QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
| Applicant | Anumana, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 28, 2025 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250652
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.