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510(k) Data Aggregation

    K Number
    K151941
    Device Name
    DEXIS Webview
    Manufacturer
    Imaging Sciences International /Gendex/Dexis
    Date Cleared
    2015-10-07

    (85 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Imaging Sciences International /Gendex/Dexis

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dexis Webview is a web-based software used for general dental and maxillofacial diagnostic image review that allows users alternate access to image data using a common web-browser. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. Dexis Webview is indicated for use only by prescription and by a trained and qualified dentist or dental technician.
    Device Description
    Dexis Webview is a web browser-based accessory software application that allows users to access preexisting imaging data remotely. Users are able to view, enhance, annotate, compare, and export preexisting images using the Dexis Core database using a web-browser. The intended use of the device is to allow dentists to be able to diagnose remotely using a traditional web-browser running on a desktop PC or Apple Mac. The Dexis Webview Software is a software program for general dental and maxillofacial diagnostic imaging. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment. It allows remote access to x-ray digital images acquired from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from intraoral dental cameras as long as they are stored in an accessible database.
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