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510(k) Data Aggregation

    K Number
    K153144
    Device Name
    TIO-H DIGITAL RADIOGRAPHY SENSOR
    Manufacturer
    Date Cleared
    2016-02-10

    (103 days)

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

    DENTTIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.
    Device Description
    The Tio-h Digital Radiography Sensor is a digital radiography imaging system. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen.
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