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510(k) Data Aggregation

    K Number
    K041782
    Device Name
    SEEMOR 5.0 IMAGE DISPLAY PROGRAM
    Manufacturer
    AREEDA ASSOC., LTD.
    Date Cleared
    2004-08-16

    (46 days)

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

    AREEDA ASSOC., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SeeMor™ 5.0 software program should be used for the transfer, display and image manipulation of multimodality diagnostic medical images and for the image than backprojection reconstruction reconstruction of SPECT & PET gated and ungated myocardial perfusion data.
    Device Description
    The SeeMor™ 5.0 medical viewing application is used for transfer and viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the command options including: clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip vertical/horizontal, set color table, orthogonal view reconstruction, cascade, tile, and reset. The ReconTool™ processing application within Seemor™ 5.0 can be used to reorient and apply tomographic reconstruction to SPECT & PET gated and ungated myocardial perfusion image data sets.
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    K Number
    K973653
    Device Name
    SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
    Manufacturer
    AREEDA ASSOC., LTD.
    Date Cleared
    1997-12-12

    (78 days)

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

    AREEDA ASSOC., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SeeMor™ software program should be used for the display and image manipulation of multimodality diagnostic medical images.
    Device Description
    This medical device (SeeMor™) is a display program for viewing diagnostic medical images. The program provides the capabilities of manipulating the images being displayed with the following command options: clipping, window/level adjustment, magnification, pan, relate, add, delete, next, cine, lock, select, view, flip vertical/horizontal, set color table, orthogonal view reconstruction, cascade, tile, and reset.
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