Cardiology
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
FDA-cleared AI medical device
Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.
FDA Submission Metadata
- Submission number
- K250652
- Decision date
- July 2025
- FDA panel
- Cardiovascular
- Product code
- QYE
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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