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FDA 510(k)

cvi42 Coronary Plaque Software Application

K-Number: K251027 · 2025-10-27

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2025-10-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

cvi42 Coronary Plaque Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K251027. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cvi42 Coronary Plaque Software Application?

cvi42 Coronary Plaque Software Application is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K251027.

When did cvi42 Coronary Plaque Software Application receive FDA 510(k) clearance?

cvi42 Coronary Plaque Software Application received FDA 510(k) clearance on 2025-10-27, under 510(k) number K251027.

Who is the listed applicant for cvi42 Coronary Plaque Software Application?

The FDA 510(k) record lists Circle Cardiovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cvi42 Coronary Plaque Software Application?

The FDA product code for cvi42 Coronary Plaque Software Application is QIH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06977295Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)RECRUITINGNCT06713239A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CADACTIVE_NOT_RECRUITING

Other records listing Circle Cardiovascular Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250221StrokeSENS ASPECTS Software ApplicationK242781cvi42 Software ApplicationK241038Cardiac CT Function Software ApplicationK232661Myocardial Strain Software ApplicationK222593TruPlan Computed Tomography (CT) Imaging SoftwareK213998cvi42 Auto Imaging Software Application

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Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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