QMW

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

Product code

QMW

Device name

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

Device class

Class 2

21 CFR

21 CFR 870.1420

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

A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

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