2 devices · 2 companies · 2024 to 2026
Product code SAT: Pulmonary Hypertension Machine Learning-Based Notification Software
2 devices under product code SAT, 2024 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Pulmonary Hypertension Machine Learning-Based Notification Software. 21 CFR 870.2380, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ECG-AI Pulmonary HypertensionK252360 · 510(k) | Anumana, Inc. | Cardiovascular | database entry | |
| CorVista System with PH Add-OnK233666 · 510(k) | Analytics for Life, Inc. | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.