Cardiac Amyloidosis Machine Learning-Based Notification Software
FDA product code SHP · Class II (moderate risk) · 21 CFR 870.2380 · Cardiovascular
Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP · Traditional | Anumana, Inc. | 04/07/2026SE |