cvi42 Coronary Plaque Software Application— 510(k) K251027

Name: FDA 510(k) clearance K251027
Creator: U.S. Food and Drug Administration
Published: 2025-10-27

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.. 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: 2025-04-02
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Circle Cardiovascular Imaging, Inc.

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K250221 — StrokeSENS ASPECTS Software Application2025-07-01
K242781 — cvi42 Software Application2024-10-15
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.