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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Artery Disease Machine Learning-Based Notification Software
510(k) Number K232686
Device Name CorVista® System
Applicant
CorVista Health, Inc.
7144 13th Place NW, Suite 2200
Washington,  DC  20012
Applicant Contact Gabrielle Zaeska
Correspondent
CorVista Health, Inc.
7144 13th Place NW, Suite 2200
Washington,  DC  20012
Correspondent Contact Gabrielle Zaeska
Classification Product Code
QXX  
Date Received09/01/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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