Pulmonary Hypertension Machine Learning-Based Notification Software

FDA product code SAT · Class II (moderate risk) · 21 CFR 870.2380 · Cardiovascular

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.

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K253699Tempus ECG-PHSAT · Traditional Tempus AI, Inc.08/21/2026SE
K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional Anumana, Inc.03/28/2026SE
K233666CorVista System with PH Add-OnSAT · Traditional Analytics For Life, Inc.04/05/2024SE