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510(k) Data Aggregation

    K Number
    K071584
    Device Name
    OASIS RELEASE 1.0
    Manufacturer
    SEGAMI CORPORATION
    Date Cleared
    2007-08-31

    (81 days)

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

    SEGAMI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data 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. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.
    Device Description
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    K Number
    K070397
    Device Name
    DGSCOPE, RELEASE 1.0
    Manufacturer
    SEGAMI CORPORATION
    Date Cleared
    2007-04-13

    (60 days)

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

    SEGAMI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.
    Device Description
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    K Number
    K070683
    Device Name
    MIRAGE CEDARS OPTION
    Manufacturer
    SEGAMI CORPORATION
    Date Cleared
    2007-04-12

    (31 days)

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

    SEGAMI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. 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
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    K Number
    K043441
    Device Name
    MIRAGE, RELEASE 5.5
    Manufacturer
    SEGAMI CORPORATION
    Date Cleared
    2005-01-13

    (30 days)

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

    SEGAMI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. 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
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