SHP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cardiac Amyloidosis Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (K253801) | Anumana, Inc. | 2026-04-07 |
Track SHP automatically
Every clearance here is in the API, with alerts when new ones post.