cvi42 Coronary Plaque Software Application— 510(k) K251027

Substantially Equivalent

Circle Cardiovascular Imaging, Inc.

FDA 510(k) clearance K251027 for cvi42 Coronary Plaque Software Application, Substantially Equivalent on 2025-10-27. Applicant: Circle Cardiovascular Imaging, Inc..

Clearance details

Applicant: Circle Cardiovascular Imaging, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-04-02
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

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