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510(k) Data Aggregation

    K Number
    K252570

    Validate with FDA (Live)

    Device Name
    EzSensor HD, EzSensor UHD
    Manufacturer
    Qpix Solutions Inc
    Date Cleared
    2025-11-10

    (88 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K242778
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EzSensor HD / UHD 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 HD / UHD is a digital intraoral sensor which 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 Indirect sensor systems is the speed with which images are acquired. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor HD / UHD includes the software (firmware) with basic level of concern.

    AI/ML Overview

    N/A

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