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510(k) Data Aggregation

    K Number
    K031874
    Device Name
    MODIFICATION TO WBR, MODEL HR
    Manufacturer
    U.C.G. TECHNOLOGIES LTD.
    Date Cleared
    2003-07-18

    (31 days)

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

    U.C.G. TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR- WB 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 image organs.
    Device Description
    The WBR - WB is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is processed by the WBR - WB, which produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
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    K Number
    K030870
    Device Name
    WBR, MODEL HR
    Manufacturer
    U.C.G. TECHNOLOGIES LTD.
    Date Cleared
    2003-04-09

    (21 days)

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

    U.C.G. TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR- HR 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 image organs.
    Device Description
    The WBR - HR is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is reconstructed by the WBR - HR, which utilizes parallel and non - parallel beams and produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
    Ask a Question

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