SAT · Class II · 21 CFR 870.2380

FDA Product Code SAT: Pulmonary Hypertension Machine Learning-based Notification Software

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.

Leading manufacturers include Anumana, Inc..

1
Total
1
Cleared
242d
Avg days
2026
Since

FDA 510(k) Cleared Pulmonary Hypertension Machine Learning-based Notification Software Devices (Product Code SAT)

1 devices
1–1 of 1
Cleared Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
K252360
Anumana, Inc.
Cardiovascular · 242d

How to use this database

This page lists all FDA 510(k) submissions for Pulmonary Hypertension Machine Learning-based Notification Software devices (product code SAT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →