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510(k) Data Aggregation

    K Number
    K061545
    Device Name
    SCENIUM 1.1
    Manufacturer
    SIEMENS MOLECULAR IMAGING LTD
    Date Cleared
    2006-06-30

    (25 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MOLECULAR IMAGING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. The software is deployed via medical imaging workstations and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.
    Device Description
    Scenium 1.1 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.
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    K Number
    K042863
    Device Name
    SCENIUM
    Manufacturer
    SIEMENS MOLECULAR IMAGING LTD
    Date Cleared
    2004-12-15

    (58 days)

    Product Code
    KPS, 90K
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MOLECULAR IMAGING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
    Device Description
    Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.
    Ask a Question

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