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510(k) Data Aggregation

    K Number
    K131434
    Device Name
    VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2013-07-16

    (60 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
    Device Description
    The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.
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    K Number
    K123467
    Device Name
    VS3
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2013-04-17

    (159 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.
    Device Description
    The VS3 consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") system is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.
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    K Number
    K082355
    Device Name
    VISIONSENSE STEREOSCOPIC VISION SYSTEM
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2008-12-15

    (122 days)

    Product Code
    HRX, GWG
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
    Device Description
    Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
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    K Number
    K082667
    Device Name
    VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2008-10-30

    (48 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VSn is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
    Device Description
    Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses --- the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
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    K Number
    K081102
    Device Name
    VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2008-05-29

    (42 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VSn system is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
    Device Description
    Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.
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    K Number
    K073279
    Device Name
    VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
    Manufacturer
    VISIONSENSE, LTD.
    Date Cleared
    2008-03-05

    (105 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIONSENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VSII system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.
    Device Description
    Not Found
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