QMW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1420
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| CADScor System (DEN190047) | Acarix A/S | 2020-11-24 |
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