Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
The Coronary Artery Disease Risk Indicator from Acoustic Heart Signals is a cardiovascular device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk score for the presence of coronary artery disease, serving as an aid in cardiac analysis and diagnosis. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.1420 in the Cardiovascular specialty. It carries product code QMW and is not an implant, not life-sustaining, and not GMP exempt.
Basic Information
- Product Code
- QMW
- Device Class
- FDA class 2
- Regulation Number
- 870.1420
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN190047 | CADScor System | Nov 24, 2020 | Unknown | Acarix A/S |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.