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FDA 510(k)

cvi42 Auto Imaging Software Application

K-Number: K213998 · 2022-07-28

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2022-07-28
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

cvi42 Auto Imaging Software Application is a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2022-07-28 under approval number K213998. 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 Auto Imaging Software Application?

cvi42 Auto Imaging Software Application is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K213998.

When was cvi42 Auto Imaging Software Application approved by the FDA?

cvi42 Auto Imaging Software Application received FDA 510(k) clearance on 2022-07-28, under approval number K213998.

What company makes cvi42 Auto Imaging Software Application?

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

What is the FDA product code for cvi42 Auto Imaging Software Application?

The FDA product code for cvi42 Auto Imaging Software Application is QIH.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging 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 NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) 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)

Other Devices by Circle Cardiovascular Imaging, Inc.

K202212TruPlan K222593TruPlan Computed Tomography (CT) Imaging Software K242781cvi42 Software Application 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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