QYE — Reduced Ejection Fraction Machine Learning-Based Notification Software Class II
FDA product code QYE covers "Reduced Ejection Fraction Machine Learning-Based Notification Software", a Class II medical device regulated under 21 CFR 870.2380. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QYE
- Device Class
- Class II
- Regulation Number
- 870.2380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250649 | bunkerhill health | Bunkerhill ECG-EF | September 19, 2025 |
| K250652 | anumana | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | July 28, 2025 |
| K250119 | tempus ai | Tempus ECG-Low EF | July 15, 2025 |
| K233409 | eko health | Eko Low Ejection Fraction Tool (ELEFT) | March 28, 2024 |
| K232699 | anumana | Low Ejection Fraction AI-ECG Algorithm | September 28, 2023 |