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510(k) Data Aggregation

    K Number
    K071054
    Device Name
    RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
    Date Cleared
    2007-05-22

    (36 days)

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

    VOLUME INTERACTIONS PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.
    Device Description
    Volume Interactions Image Processing System reads DICOM 3.0 format medical image data sets (and other formats) and displays 3D image reconstructions of these data sets through various user selectable industry standard rendering methods and algorithms. The clinical users can spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes in the 3D image reconstructions. The processed data can be stored either as 3D image data in a proprietary format, or as 2D picture projections of the 3D image data in TIFF image format. The system runs on commercially available PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems. The system consists of three product modules namely, RadioDexter™, Dextroscope™ and Dextrobeam™. The modules are described as follows: RadioDexter™ is software that processes tomographic (e.g.: Computer Tomography, Magnetic Resonance Imaging) data and produces stereoscopic 3D renderings for surgery planning and visualization purposes. The software uses various user selectable industry standard rendering methods and algorithms. DTI (Diffusion Tensor Imaging) is an add-on module to RadioDexter™. This module allows the user to visualize white matter anatomy in the form of fiber tracks. The intended use of this module is to generate and provide a visual reference of white matter fiber tracks in a 3D virtual reality environment during the process of neurosurgery planning using the Dextroscope™ or during a discussion/collaboration using the Dextrobeam™. It is not intended to be used otherwise. Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the RadioDexter™ software. The Dextroscope™ user works seated, with both forearms positioned on armrests. Wearing stereoscopic glasses, the user looks into a mirror and perceives the virtual image within comfortable reach of both hands for precise hand-eye coordinated manipulation. The hardware uses various industry standard components. Dextrobeam™ is an interactive console intended for group collaborative discussions with 3D images using a stereoscopic projection system. The Dextrobeam™ system uses the base of the Dextroscope™ as the 3D interaction interface with the virtual objects. The monitor of the Dextroscope™ is replaced by a screen projection system, so instead of looking into the mirror of the Dextroscope™, the user looks at large stereoscopic screen projections while working with the virtual data in reach of his hands. This enables the discussion of 3D data sets with other specialists in stereoscopic 3D. The hardware uses various industry standard components.
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    K Number
    K063730
    Device Name
    DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
    Date Cleared
    2007-01-31

    (44 days)

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

    VOLUME INTERACTIONS PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.
    Device Description
    Image Processing System (Dextroscope™ MK10, Dextrobeam™ MK3 and MK4, RadioDexter™ 1.0)
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    K Number
    K053162
    Device Name
    DEXTROSCOPE & DEXTROBEAM
    Date Cleared
    2005-12-09

    (25 days)

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

    VOLUME INTERACTIONS PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from tomographic radiology images. It is intended to be used by qualified and trained medical professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.
    Device Description
    Image Processing System
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    K Number
    K032924
    Device Name
    RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
    Date Cleared
    2003-10-10

    (18 days)

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

    VOLUME INTERACTIONS PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.
    Device Description
    Image Processing System (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3)
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    K Number
    K022938
    Device Name
    VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
    Date Cleared
    2002-10-25

    (51 days)

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

    VOLUME INTERACTIONS PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.
    Device Description
    Volume Interactions Image Processing System reads DICOM 3.0 format medical image data sets (and other formats) and displays 3D image reconstructions of these data sets through various user selectable industry standard rendering methods and algorithms. The clinical users can spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes in the 3D image reconstructions. The processed data can be stored either as 3D image data in a proprietary format. or as 2D picture projections of the 3D image data in TIFF image format. The system runs on commercially available IBM PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems. The system consists of three product modules namely, VizDexter™ 2.0, Dextroscope™ and DextroBeam™. The modules are described as follows: VizDexter™ 2.0 is software that processes tomographic (e.g.: Computer Tomography, Magnetic Resonance Imaging) data and produces stereoscopic 3D renderings for surgery planning and visualization purposes. The software user selectable industry standard rendering methods and algorithms. Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the VizDexter™ software. The Dextroscope™ user works seated, with both forearms positioned on armrests. Wearing stereoscopic glasses, the user looks into a mirror and perceives the virtual image within comfortable reach of both hands for precise hand-eye coordinated manipulation. The hardware uses various industry standard components. DextroBeam™ is an interactive console intended for group collaborative discussions with 3D images using a stereoscopic projection system. The DextroBeam™ system uses the base of the Dextroscope™ as the 3D interaction interface with the virtual objects. The monitor of the Dextroscope™ is replaced by a screen projection system, so instead of looking into the mirror of the Dextroscope™, the user looks at large stereoscopic screen projections while working with the virtual data in reach of his hands. This enables the discussion of 3D data sets with other specialists in stereoscopic 3D. The hardware uses various industry standard components.
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