meddevicedb.com FDA Device Reference

CADScor System

DEN190047 Class II Direct
Decision Date
2020-11-24
Sponsor / Applicant
Acarix A/S

Technical Specification

510(k) Submission ID DEN190047
Product Code QMW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1420
Decision Date 2020-11-24
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

CADScor System received FDA 510(k) clearance under submission number DEN190047, sponsored by Acarix A/S. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-11-24.

Classification & Regulation

This clearance is catalogued under FDA product code QMW and 21 CFR 870.1420, within the Cardiovascular review panel as a Class II device.