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FDA 510(k)

Cardiac CT Function Software Application

K-Number: K241038 · 2024-06-07

ApplicantCircle Cardiovascular Imaging
Decision Date2024-06-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cardiac CT Function Software Application is a medical device manufactured by Circle Cardiovascular Imaging. It received FDA 510(k) clearance on 2024-06-07 under approval number K241038. 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 Cardiac CT Function Software Application?

Cardiac CT Function Software Application is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Circle Cardiovascular Imaging. The 510(k) number is K241038.

When was Cardiac CT Function Software Application approved by the FDA?

Cardiac CT Function Software Application received FDA 510(k) clearance on 2024-06-07, under approval number K241038.

What company makes Cardiac CT Function Software Application?

Cardiac CT Function Software Application is manufactured by Circle Cardiovascular Imaging.

What is the FDA product code for Cardiac CT Function Software Application?

The FDA product code for Cardiac CT Function Software Application is QIH.

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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

K232661Myocardial Strain 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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