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510(k) Data Aggregation

    K Number
    K111336
    Device Name
    EBW NM 2.0
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Date Cleared
    2011-05-24

    (12 days)

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

    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure. The data processed may be derived from any nuclear medicine camera. EBW NM 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
    Device Description
    EBW NM 2.0 is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities.
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