QYE · Reduced Ejection Fraction Machine Learning-Based Notification Software
Cardiovascular · 21 CFR 870.2380 · Class 2
Overview
| Product Code | QYE |
|---|---|
| Device Name | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Regulation | 21 CFR 870.2380 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
Viz HCM is a cardiovascular machine learning-based notification software intended to be used in parallel to the standard of care to analyze 12-lead ECG recordings from patients 18 years of age or older. It detects signs associated with hypertrophic cardiomyopathy (HCM) and allows the user to view the ECG and analysis results. It is not intended for use on patients with implanted pacemakers, does not replace standard diagnostic methods, and is not intended to rule out HCM or be used in lieu of a full patient evaluation.
Classification Rationale
Class II (special controls). The device is a cardiovascular machine learning-based notification software, regulated under 21 CFR 870.2380.
Special Controls
In combination with the general controls of the FD&C Act, cardiovascular machine learningbased notification software is subject to the following special controls:
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | Sep 19, 2025 | SESE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | Jul 28, 2025 | SESE |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | Jul 15, 2025 | SESE |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | Mar 28, 2024 | SESE |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | Sep 28, 2023 | SESE |
Top Applicants
- Anumana, Inc. — 2 clearances
- BunkerHill Health — 1 clearance
- Eko Health, Inc. — 1 clearance
- Tempus AI, Inc. — 1 clearance
