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510(k) Data Aggregation

    K Number
    K021072
    Device Name
    FILMSAVER, NT VERSION 5.03
    Manufacturer
    AMERICAN MEDICAL RESOURCES, LTD. (AMR)
    Date Cleared
    2002-06-06

    (65 days)

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

    AMERICAN MEDICAL RESOURCES, LTD. (AMR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FilmSaver NT Version 5.03 software is intended to reduce the total film consumption of a CT scanner, MRI, etc. by reducing the area needed for the diagnostic image. The device uses propriety software algorithms to receive, process, and send analog or digital radiological images. The FilmSaver product is designed to interface with industry standard radiology equipment.
    Device Description
    FilmSaver NT Version 5.03 software
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