SAT
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Medical specialty
- Cardiovascular
- FDA definition
- Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.
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| Record | Firm | Date |
|---|---|---|
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (K252360) | Anumana, Inc. | 2026-03-28 |
| CorVista System with PH Add-On (K233666) | Analytics For Life, Inc. | 2024-04-05 |
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Every clearance here is in the API, with alerts when new ones post.