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510(k) Data Aggregation

    K Number
    K220556
    Device Name
    OpenSensorX Series
    Manufacturer
    Date Cleared
    2022-04-13

    (44 days)

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

    DentiMax, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OpenSensorX Series is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.
    Device Description
    OpenSensorX series are digital intra-oral sensors. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional iRay intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of the OpenSensorX series is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The OpenSensorX series has two device models, OpenSensor0001X and OpenSensor0002X.
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