Panels › Cardiovascular › Product code SHP · Class 2
Cardiac Amyloidosis Machine Learning-Based Notification Software
Regulation 870.2380
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SHP
| Company | 510(k)s | Recalls |
|---|---|---|
| Anumana, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2026 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) Anumana, Inc. | SHP |
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