Low Ejection Fraction AI-ECG Algorithm
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232699 FDA 510(k)
- FDA Product Code
- QYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2380 FDA 510(k)
- Regulation Number
- 870.2380 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Reduced Ejection Fraction Machine Learning-Based Notification Software (per FDA classification QYE), designed to analyze electrocardiogram (ECG) data and identify patients with low left ventricular ejection fraction (LEF). It employs artificial intelligence to assist clinicians in detecting early signs of heart failure by processing routine 12-lead ECG recordings.
The algorithm is supplied as a software solution for integration with ECG systems and is intended for single-use per patient assessment. It operates in clinical settings, including hospitals and cardiology practices, and requires no special sterility measures beyond standard ECG device hygiene. Authorized under FDA 510(k) clearance (K232699), it adheres to regulatory standards for cardiovascular software (regulation number 870.2380) and is classified as a Class II device.
Frequently asked questions
How does the Low Ejection Fraction AI-ECG Algorithm assist clinicians in identifying heart failure risks during routine care?
The algorithm analyzes standard 12-lead ECG recordings using artificial intelligence to detect early signs of low left ventricular ejection fraction (LVEF), a key indicator of heart failure. By integrating with existing ECG systems, it provides automated notifications to help clinicians identify patients at risk during routine assessments, enabling earlier intervention.
Is the Low Ejection Fraction AI-ECG Algorithm reusable for multiple patients, or is it designed for single-use?
The device is explicitly designed for single-use per patient assessment, meaning each analysis is intended for one individual evaluation. This aligns with its classification as software for diagnostic use, where patient-specific data integrity is prioritized.
What hygiene or sterility precautions are required when using this algorithm in a clinical setting?
Since the algorithm is a software solution integrated with ECG systems, no specialized sterility measures are needed beyond standard hygiene protocols for ECG devices. The focus remains on maintaining cleanliness of the hardware components used to capture the ECG data, as the software itself does not require physical sterilization.
How is this algorithm regulated, and what does its FDA clearance status mean for healthcare providers?
The Low Ejection Fraction AI-ECG Algorithm holds FDA 510(k) clearance (K232699) under the classification of *Reduced Ejection Fraction Machine Learning-Based Notification Software* (product code QYE). This means it has been determined *substantially equivalent* to a legally marketed predicate device and adheres to regulatory standards for cardiovascular software (regulation 870.2380). For providers, this indicates it meets established safety and effectiveness criteria for use in clinical settings.
Where can this algorithm be implemented, and what types of healthcare facilities would benefit most?
The algorithm is designed for integration into clinical settings such as hospitals and cardiology practices, where routine 12-lead ECGs are performed. It is particularly useful in environments where early detection of low LVEF is critical, such as cardiology clinics, emergency departments, or cardiac rehabilitation programs, to support timely patient management.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LEF - Anumana, Anumana - Unlocking the Language of the Heart, Anumana ECG-AI LEF Algorithm Receives FDA Clearance, Anumana Low EF AI-ECG Algorithm and Care-as-Usual in Ventricular ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232699 | Class II | Active |
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Manufacturer
- Manufacturer
- Anumana, Inc.
Sources (1)
- FDA 510(k) K232699 24 fields · synced Sep 19, 2026