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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 a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2025-10-27 under approval 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. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K251027.

When was cvi42 Coronary Plaque Software Application approved by the FDA?

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

What company makes cvi42 Coronary Plaque Software Application?

cvi42 Coronary Plaque Software Application is manufactured by Circle Cardiovascular Imaging, Inc..

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

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT05755711 Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT07592377 Multicenter Study on the Use of a Collagen-based Hydrogel for the Treatment of 153 Periodontal Pockets in 38 Adults With Generalized Stage III Periodontitis COMPLETED NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING NCT06257069 Tremor Retrainer Software Application for Functional Tremor ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Other Devices by Circle Cardiovascular Imaging, Inc.

K202212TruPlan K213998cvi42 Auto Imaging Software Application K222593TruPlan Computed Tomography (CT) Imaging Software K242781cvi42 Software Application K250221StrokeSENS ASPECTS Software Application

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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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