QXX

Coronary Artery Disease Machine Learning-Based Notification Software

Product code

QXX

Device name

Coronary Artery Disease 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 (all years, FDA)

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

FDA classification definition

Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.

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