510(k) K232686

CorVista® System by Corvista Health, Inc. — Product Code QXX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2023
Date Received: September 1, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Coronary Artery Disease Machine Learning-Based Notification Software
Device Class: Class II
Regulation Number: 870.2380
Review Panel: CV
Submission Type

Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.