DeviceClearance

Product code QMW— Cardiovascular

CADScor System

Classification name
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Device class
Class 2
Regulation
21 CFR 870.1420
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QMW under 21 CFR 870.1420, via openFDA

Market context for product code QMW

FDA has cleared 1 device under product code QMW, all in 2020, filed by 1 applicant company. 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.

Top applicants under product code QMW

Recent clearances under product code QMW

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