cvi42 Software Application— 510(k) K242781

Name: FDA 510(k) clearance K242781
Creator: U.S. Food and Drug Administration
Published: 2024-10-15

Substantially Equivalent

Circle Cardiovascular Imaging, Inc.

FDA 510(k) clearance K242781 for cvi42 Software Application, Substantially Equivalent on 2024-10-15. Applicant: Circle Cardiovascular Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Circle Cardiovascular Imaging, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-16
Decision date: 2024-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Circle Cardiovascular Imaging, Inc.

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K251027 — cvi42 Coronary Plaque Software Application2025-10-27
K250221 — StrokeSENS ASPECTS Software Application2025-07-01
K222593 — TruPlan Computed Tomography (CT) Imaging Software2023-01-18
K213998 — cvi42 Auto Imaging Software Application2022-07-28
K202212 — TruPlan2021-02-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.