510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190047Unknown

CADScor System

Acarix AS, Hellerup, DK / Direct, Unknown
FDA source (opens on fda.gov)

DEN190047 is the FDA 510(k) clearance record for CADScor System, a class II device, cleared for Acarix A/S on under FDA product code QMW (Coronary Artery Disease Risk Indicator From Acoustic Heart Signals). FDA's definition for product code QMW reads: "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...". FDA records list one 510(k) clearance for Acarix A/S. As of , FDA records show no recalls naming DEN190047.

Clearance record

Decision date
Received
(386 days to decision)
Product code
QMW Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Regulation
21 CFR 870.1420
Device class
Class II
Review panel
Cardiovascular
Applicant
Acarix A/S Ryvangs Alle 81, Hellerup, DK
Third party review
No

Clearances, product code QMW

Trailing 12 months

FDA records hold no clearances under product code QMW in the trailing twelve months.

FDA records show no clearances under product code QMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260