DeviceClearance

Product code SAT— Cardiovascular

CorVista System with PH Add-On

Classification name
Pulmonary Hypertension Machine Learning-Based Notification Software
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SAT under 21 CFR 870.2380, via openFDA

Market context for product code SAT

FDA has cleared 3 devices under product code SAT between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAT

Recent clearances under product code SAT

Data sourced from openFDA. This site is unofficial and independent of the FDA.