SAT

Pulmonary Hypertension Machine Learning-Based Notification Software

Product code

SAT

Device name

Pulmonary Hypertension Machine Learning-Based Notification Software

Device class

Class 2

21 CFR

21 CFR 870.2380

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-08-21.

2 summaries are archived here for direct download.