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510(k) Data Aggregation

    K Number
    K182611
    Device Name
    Qangio XA 3D
    Manufacturer
    Medis Medical Imaging Systems bv
    Date Cleared
    2019-05-30

    (251 days)

    Product Code
    QHA, LLZ
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medis Medical Imaging Systems bv

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QANGIO XA 3D is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QANGIO XA 3D are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
    Device Description
    QANGIO XA 3D is the Medis software solution for the quantitative analysis of cardiac X-ray Angiography (XA) studies. QANGIO XA 3D features: - Acquisition guide and series selection guide - Annotations and basic measurements - 2D and 3D OCA vessel detection - 2D and 3D OCA vessel quantification - QFR calculations: Quantitative Flow Ratio (QFR) analysis with fixed flow model (fQFR) and contrast flow models (cQFR). - Single vessel report QANGIO XA 3D will be used by interventional cardiologists and researchers to obtain quantifications of lesions in coronary vessels, to determine the functional significance of the individual or consecutive multiple lesions, prior, during or after percutaneous coronary intervention treatment. QANGIO XA 3D has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.
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