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510(k) Data Aggregation

    K Number
    K010726
    Device Name
    MODIFICATION TO MIRAGE
    Manufacturer
    SEGAMI CORP., INC.
    Date Cleared
    2001-04-26

    (45 days)

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

    SEGAMI CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972886
    Device Name
    MIRAGE
    Manufacturer
    SEGAMI CORP., INC.
    Date Cleared
    1997-10-01

    (57 days)

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

    SEGAMI CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
    Device Description
    The product (Mirage) is basically a camera driven acquisition, processing and postprocessing (visualization and analysis) software system with a Patient Data Management system, to which minimal processing (e.g. tomographic reconstruction) has been added.
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