Cardiac CT Function Software Application— 510(k) K241038

Name: FDA 510(k) clearance K241038
Creator: U.S. Food and Drug Administration
Published: 2024-06-07

Substantially Equivalent

Circle Cardiovascular Imaging

FDA 510(k) clearance K241038 for Cardiac CT Function Software Application, Substantially Equivalent on 2024-06-07. Applicant: Circle Cardiovascular Imaging. Device class: 2.

Clearance details

Applicant: Circle Cardiovascular Imaging
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-04-16
Decision date: 2024-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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