5 devices · 4 companies · 2023 to 2025
Product code QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software
5 devices under product code QYE, 2023 to 2025, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Reduced Ejection Fraction Machine Learning-Based Notification Software. 21 CFR 870.2380, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Bunkerhill ECG-EFK250649 · 510(k) | BunkerHill Health | Cardiovascular | database entry | |
| ECG-AI Low Ejection FractionK250652 · 510(k) | Anumana, Inc. | Cardiovascular | database entry | |
| Tempus ECG-Low EFK250119 · 510(k) | Tempus AI, Inc. | Cardiovascular | database entry | |
| Eko Low Ejection Fraction ToolK233409 · 510(k) | Eko Health, Inc. | Cardiovascular | database entry | |
| Low Ejection Fraction AI-ECG AlgorithmK232699 · 510(k) | Anumana, Inc. | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.