Panels › Cardiovascular › Product code QYE · Class 2
Reduced Ejection Fraction Machine Learning-Based Notification Software
Regulation 870.2380
1510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Anumana, Inc. | 2 | 0 |
| BunkerHill Health | 1 | 0 |
| Eko Health, Inc. | 1 | 0 |
| Medical AI Co., Ltd. | 1 | 0 |
| Tempus AI, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K254302 | ECG Analysis Software (AiTiALVSD) Medical AI Co., Ltd., KR | QYE |
| Sep 19, 2025 | K250649 | Bunkerhill ECG-EF BunkerHill Health | QYE |
| Jul 28, 2025 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) Anumana, Inc. | QYE |
| Jul 15, 2025 | K250119 | Tempus ECG-Low EF Tempus AI, Inc. | QYE |
| Mar 28, 2024 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) Eko Health, Inc. | QYE |
| Sep 28, 2023 | K232699 | Low Ejection Fraction AI-ECG Algorithm Anumana, Inc. | QYE |
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