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510(k) Data Aggregation

    K Number
    K092537
    Device Name
    DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
    Manufacturer
    TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC.
    Date Cleared
    2009-08-27

    (8 days)

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

    TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Toshiba Digital X-ray Sensor is an intraoral receiver of X-ray energy by the dentist to obtain instant digital images of teeth and the oral cavity of patients. Images are transmitted to a computer for display.
    Device Description
    The Digital X-ray Sensor is an intraoral receiver of X-ray energy used by the dentist to obtain instant digital images of teeth and the oral cavity of patients. Images are transmitted to a computer for display. The Digital X-ray Sensor is composed by following components: 1) Sensor head 2) Controller 3) USB cable 4) Driver software
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