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510(k) Data Aggregation

    K Number
    K201172
    Device Name
    CFP-3131, CFP-2222
    Manufacturer
    Date Cleared
    2020-05-29

    (28 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MX Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in radiographic fluoroscopic applications including cardiar, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
    Device Description
    These CMOS X-ray detectors feature: The MX Imaging CMOS Flat Panel Detectors are designed for medical x-ray imaging applications. The CMOS panels are real-time x-ray detectors. The Detectors use a state of the art CMOS Imaging sensor that is based on a special pixel architecture enabling the detectors to be used in high sensitivity applications such as x-ray fluoroscopy/pulsed fluoroscopy, as well as applications requiring a large dynamic x-ray range such as radiography serial and radiography applications. The CMOS Flat Panel Detector is a component, and forms the part of a complete fluoroscopic x-ray system. The CMOS Detector interfaces to the Host X-Ray System through the associated interface connectors on the flat panel. The CMOS Flat Panel Detector is also synchronized to the X-Ray Generator via the interface cables. The intended use for this device is for Image Intensifier replacement in legacy surgical C-Arm systems.
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