cvi42 Auto Imaging Software Application— 510(k) K213998

Substantially Equivalent

Circle Cardiovascular Imaging, Inc.

FDA 510(k) clearance K213998 for cvi42 Auto Imaging Software Application, Substantially Equivalent on 2022-07-28. Applicant: Circle Cardiovascular Imaging, Inc..

Clearance details

Applicant: Circle Cardiovascular Imaging, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2021-12-21
Decision date: 2022-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

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