| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-06-15 | K260300 | WatchMate Software | Anumana, Inc. | Radiology |
| 2026-04-07 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | Cardiovascular |
| 2026-03-28 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | Cardiovascular |
| 2025-07-28 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | Cardiovascular |
| 2023-09-28 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | Cardiovascular |