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    K Number
    K020300
    Device Name
    NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2002-04-23

    (84 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K992450
    Why did this record match?
    Device Name :

    NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Northwestern Gated Blood Pool SPECT (NUMUGAS™) software program is indicated to use for the display of wall motion and quantification of left ventricular functional parameters from gated Tc-99m Blood Pool SPECT studies.

    Device Description

    The Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) is used to display gated wall motion and for quantifying parameters of left-ventricular function from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

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