QYE
5 FDA 510(k) clearances · Product code
174 daysmedian time to decision
199 days90th percentile
5clearances measured
FDA profile
- Official device name
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Bunkerhill ECG-EF (K250649) | BunkerHill Health | 2025-09-19 |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (K250652) | Anumana, Inc. | 2025-07-28 |
| Tempus ECG-Low EF (K250119) | Tempus AI, Inc. | 2025-07-15 |
| Eko Low Ejection Fraction Tool (ELEFT) (K233409) | Eko Health, Inc. | 2024-03-28 |
| Low Ejection Fraction AI-ECG Algorithm (K232699) | Anumana, Inc. | 2023-09-28 |
Track QYE automatically
Every clearance here is in the API, with alerts when new ones post.