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510(k) Data Aggregation

    K Number
    K012439
    Device Name
    DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
    Manufacturer
    RADCO DATA AB
    Date Cleared
    2002-02-06

    (190 days)

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

    RADCO DATA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for acquisition, storage, display, and manipulation of Dental Images Acquiring and handling of radiographs and color images Viewing and manipulation for insurance claims adjudication Viewing and manipulation for diagnostic purposes Viewing for patient education and consultation including cosmetic imaging.
    Device Description
    Intended uses in the dental industry include the following: Acquiring and handling of radiographs and color images: Viewing and manipulation for insurance claims adjudication Viewing and manipulation for diagnostic purposes Viewing for patient education and consultation including cosmetic imaging.
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