ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) is an AI-enabled medical device from Anumana, Inc., listed by FDA (510(k), K250652) with a decision date of 2025-07-28. Review panel: Cardiovascular.
| FDA submission number | K250652 |
|---|---|
| Pathway | 510(k) |
| Company | Anumana, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-07-28 |
| Decision | Substantially Equivalent |
| Product code | QYE |
| Classification | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Device class | 2 |
| Regulation number | 870.2380 |
| Review time (calendar days) | 146 |
| Applicant country | US |
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.