SAT — Pulmonary Hypertension Machine Learning-Based Notification Software Class II

FDA Device Classification

Classification Details

Product Code
SAT
Device Class
Class II
Regulation Number
870.2380
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252360anumanaECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)March 28, 2026
K233666analytics for lifeCorVista System with PH Add-OnApril 5, 2024