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510(k) Data Aggregation

    K Number
    K990383
    Device Name
    APOLLO 5, APOLLO 10
    Manufacturer
    PRECITRON A.B.
    Date Cleared
    1999-05-05

    (86 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECITRON A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apollo 5 and Apollo 10 In-Vivo Dosimetry systems are used to provide dose measurement capabilities for dose verification and quality assurance for patients undergoing radiation therapy.
    Device Description
    Not Found
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