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FDA 510(k)

cvi42 Software Application

K-Number: K242781 · 2024-10-15

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2024-10-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

cvi42 Software Application is a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2024-10-15 under approval number K242781. 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 Software Application?

cvi42 Software Application is a medical device that received FDA 510(k) clearance on 2024-10-15. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K242781.

When was cvi42 Software Application approved by the FDA?

cvi42 Software Application received FDA 510(k) clearance on 2024-10-15, under approval number K242781.

What company makes cvi42 Software Application?

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

What is the FDA product code for cvi42 Software Application?

The FDA product code for cvi42 Software Application is QIH.

Related Clinical Trials

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Related PubMed Literature

PMID: 39698124 Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD). IEEE open journal of engineering in medicine and biology (2025) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

Other Devices by Circle Cardiovascular Imaging, Inc.

K202212TruPlan K213998cvi42 Auto Imaging Software Application K222593TruPlan Computed Tomography (CT) Imaging Software K251027cvi42 Coronary Plaque Software Application K250221StrokeSENS ASPECTS Software Application

Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, 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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