QMW — Coronary Artery Disease Risk Indicator From Acoustic Heart Signals Class II
FDA product code QMW covers "Coronary Artery Disease Risk Indicator From Acoustic Heart Signals", a Class II medical device regulated under 21 CFR 870.1420. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QMW
- Device Class
- Class II
- Regulation Number
- 870.1420
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190047 | acarix | CADScor System | November 24, 2020 |