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510(k) Data Aggregation

    K Number
    K001445
    Device Name
    SMILIE PC
    Manufacturer
    JULIE ALLIANCE
    Date Cleared
    2000-07-26

    (79 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    JULIE ALLIANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990002
    Device Name
    QUICKRAY DSX 730
    Manufacturer
    JULIE ALLIANCE
    Date Cleared
    1999-04-01

    (87 days)

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

    JULIE ALLIANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.
    Device Description
    The QuickRay DSX 730 sensor device and related components. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.
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