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510(k) Data Aggregation

    K Number
    K232976
    Device Name
    VUZE System
    Manufacturer
    Date Cleared
    2024-05-09

    (231 days)

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

    VUZE Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.
    Device Description
    The VUZE System (the "System") enables users to load 3D images and planning data then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation. fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The System offers optional pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intra-operative 2D images onto a patient's pre-operative 3D images. The System's main components include: - A workstation running the VUZE Planning and Procedure software (pre-installed) - A housing for the workstation, with a front door for user access as well as a back service door - A 32" touchscreen - A mouse - An isolation transformer - An internal video acquisition device (frame grabber) - A minimal-footprint, wheeled cart on which the above-listed items are placed. - DVI cable with galvanic isolator - An optional standalone planning station (planning software running on a commercial PC with identified specifications) - Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle (Note: The orientation sensor may also be referred to under an acronym of IMU) - Optional OTS foot pedal and associated Bluetooth dongle
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    K Number
    K210830
    Device Name
    VUZE System
    Manufacturer
    Date Cleared
    2022-01-03

    (290 days)

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

    VUZE Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.
    Device Description
    The VUZE System (the "System") enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The System offers pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative quidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intraoperative 2D images onto a patient's pre-operative 3D images. The main system components include: - Workstation running the VUZE Planning and Procedure software (pre-installed) - Housing for the workstation, with a front door for user access as well as a back service door - 32" touchscreen - Isolation transformer - Internal video acquisition device (frame grabber) - Wheeled cart on which the above-listed items are placed.
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