ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Device Facts
| Record ID | K253801 |
|---|---|
| Device Name | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) |
| Applicant | Anumana, Inc. |
| Product Code | SHP · Cardiovascular |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2380 |
| Device Class | Class 2 |
Regulatory Classification
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.
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:
