Reduced Ejection Fraction Machine Learning-Based Notification Software
The reduced ejection fraction machine learning-based notification software (product code QYE) is a Class 2 Cardiovascular device (regulation 870.2380) that employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up. Requiring 510(k) clearance, it provides notification output intended as the basis for additional evaluation rather than as a standalone diagnostic. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QYE
- Device Class
- FDA class 2
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250649 | Bunkerhill ECG-EF | Sep 19, 2025 | Substantially Equivalent | BunkerHill Health |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Jul 28, 2025 | Substantially Equivalent | Anumana, Inc. |
| K250119 | Tempus ECG-Low EF | Jul 15, 2025 | Substantially Equivalent | Tempus AI, Inc. |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Mar 28, 2024 | Substantially Equivalent | Eko Health, Inc. |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Sep 28, 2023 | Substantially Equivalent | Anumana, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.