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510(k) Data Aggregation

    K Number
    K140445
    Device Name
    DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
    Manufacturer
    IMAGING SCIENCES INTERNATIONAL, LLC
    Date Cleared
    2014-04-23

    (61 days)

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

    IMAGING SCIENCES INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
    Device Description
    The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
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