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510(k) Data Aggregation

    K Number
    K232255
    Device Name
    EZSensor XHD
    Manufacturer
    Qpix Solutions Inc.
    Date Cleared
    2023-09-27

    (61 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qpix Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EzSensor XHD is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
    Device Description
    EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.
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