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510(k) Data Aggregation

    K Number
    K062788
    Device Name
    COLLIMATOR, MODEL M-38
    Manufacturer
    UMI INTERNATIONAL
    Date Cleared
    2006-12-28

    (101 days)

    Product Code
    KPW
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    UMI INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
    Device Description
    Collimator (manual drive) – a beam limiting device
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