510(k) K253801 ยท SHP Cardiac Amyloidosis Machine Learning-Based Notification Software
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
| Applicant | Anumana, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253801
No recall in the FDA data names this 510(k).
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