Reduced Ejection Fraction Machine Learning-Based Notification Software
FDA product code QYE · Class II (moderate risk) · 21 CFR 870.2380 · Cardiovascular
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.
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250649 | Bunkerhill ECG-EFQYE · Traditional | BunkerHill Health | 09/19/2025SE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | Anumana, Inc. | 07/28/2025SE |
| K250119 | Tempus ECG-Low EFQYE · Traditional | Tempus AI, Inc. | 07/15/2025SE |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT)QYE · Traditional | Eko Health, Inc. | 03/28/2024SE |
| K232699 | Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional | Anumana, Inc. | 09/28/2023SE |