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510(k) Data Aggregation

    K Number
    K222036
    Device Name
    MPXA-2000
    Manufacturer
    Date Cleared
    2023-03-22

    (254 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medipixel, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MPXA-2000 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the coronary arteries, for use on individual patients with coronary artery disease (CAD). MPXA-2000 is indicated for use in adult patient only. When the quantified results provided by MPXA-2000 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
    Device Description
    MPXA-2000, the stand-alone application, is cardiovascular image analysis software for the viewing and quantification of X-ray angiographic images of the coronary arteries. Automatic vessel contour detection (i.e. vessel segmentation) forms the basis for the analyses. MPXA-2000 provides automatic analysis through segmentation of vessels and calculation of the segmented vessel's dimensions. MPXA-2000 is developed based on Deep-learning (Classification and Segmentation of vessels) and Computer vision algorithms (Measurements of vessels) to analyze the images and provide quantification of the vessels in real-time. It allows accurate and reproducible quantification of the coronary arteries from a set of those images in DICOM format. MPXA-2000 is composed of the following key analysis workflow and functionalities: - Image Uploading, Frame Selection - Vessel Segmentation - Classification of Vessel types - ROIs (regions of Interest) Quantification - Visualization & Export of the Analysis Results. The analysis results are available on the screen and can be exported in PDF or Excel file format. MPXA-2000 has been validated for the images produced by FDA-approved X-ray angiography systems from Philips Medical Systems, Siemens Healthineers, GE Healthcare. The input data should be X-ray angiographic images that comply with the DICOM standard.
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