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510(k) Data Aggregation

    K Number
    K111102
    Device Name
    RADIOVISION
    Manufacturer
    Date Cleared
    2011-05-05

    (15 days)

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

    HAAS SOFTWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images.
    Device Description
    RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images. Records are stored in a SQL database, searchable by any of the database table column names. The database stores basic patient information and digital image data without compression. Basic image enhancement information is also stored to the database so that the images can be re-displayed at a later time with enhancements applied, without altering the original image data. Images may be assembled into layouts which can be customized as required. RadioVision includes standard enhancements such as brightness, contrast, sharpening and false color. Additional advanced controls are also available such as histogram equalization and the CrystalView and Highlight filters. RadioVision includes an automatic backup feature that allows the database to be backed up once each day at a specific time, and will create time-stamped copies of the database so that one can return to a specific point in time. Radio Vision also includes the ability to restore a previously created database backup.
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