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510(k) Data Aggregation

    K Number
    K062386
    Device Name
    QANGIO CT
    Date Cleared
    2006-10-05

    (51 days)

    Product Code
    Regulation Number
    892.1750
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    QANGIO CT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    QAngio CT software solution has been developed for the objective and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics. QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists and radiologists.

    Device Description

    QAngio CT is able to read DICOM CT images from all major CT scanner vendors. Vessel analysis data, generated by automated (and/or manual) segmentation, detected stenosis, and quantitative results, can be saved in separate files enabling the comparison of results from different users. Radiologists, cardiologists and technicians use the QAngio CT analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment. In clinical practice the QAngio CT software is used on workstations in review rooms or integrated in a PACS environment.

    AI/ML Overview

    The provided text does not contain information regarding the acceptance criteria, specific study details (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or standalone performance), or the type of ground truth used.

    The document is a 510(k) summary for a medical device called QAngio CT, which is a software for the quantitative analysis of CT angiograms. It describes the device's intended use and claims substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

    Therefore, I cannot provide the requested table and study details based on the given input.

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