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510(k) Data Aggregation

    K Number
    K041580
    Device Name
    IMAGERAYI
    Manufacturer
    HENRY SCHEIN, INC.
    Date Cleared
    2004-06-29

    (15 days)

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

    HENRY SCHEIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.
    Device Description
    digital x-ray sensor system
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