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510(k) Data Aggregation

    K Number
    K103710
    Device Name
    WBR XPRESS PET
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2011-01-19

    (30 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy 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 WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).
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    K Number
    K091073
    Device Name
    WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2009-05-14

    (30 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).
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    K Number
    K081201
    Device Name
    WBR XPRESS3.CARDIAC
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2008-05-28

    (30 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xpress3.Cardiac 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, ind in various forms of animated sequences, showing kinetic attributes of the image organs.
    Device Description
    The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce 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
    K080784
    Device Name
    WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2008-04-02

    (13 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR Half Dose 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 Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.
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    K Number
    K050815
    Device Name
    XACT.CARDIAC & XPRESS.CARDIAC
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2005-04-26

    (26 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce 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
    K040370
    Device Name
    WBR-FHR, WBR-FWB
    Manufacturer
    ULTRASPECT LTD.
    Date Cleared
    2004-03-11

    (27 days)

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

    ULTRASPECT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.
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