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510(k) Data Aggregation

    K Number
    K191579
    Device Name
    Voyant System
    Manufacturer
    Viseon, Inc.
    Date Cleared
    2019-07-11

    (27 days)

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

    Viseon, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.
    Device Description
    The Voyant System is composed of the Voyant Sheath and Voyant Imager, and Accessories which includes an Image Control Box (ICB) and connecting cables. The Voyant Sheath and Voyant Imager are supplied sterile by ethylene oxide (EtO) while the ICB and connecting cables are supplied non-sterile and are reusable. The Voyant System is used in minimally invasive spine surgery to provide access and visualization of the surgical area of the spine. The Voyant System is a sterile, single-use access and visualization device consisting of a Sheath for access to the spine and an Imager for illumination and visualization of the surgical area. The Sheaths are available in multiple diameters and lengths to accommodate a variety of patient anatomies and spinal surgical procedures. Likewise, the Voyant Imager is available in corresponding diameters to attach to the Voyant Sheath. The Voyant Imager connects to the Image Control Box (ICB) via an HDMI cable and live video image is displayed to a connected external HD monitor in the operating room. The ICB functions to power the Voyant Imager, process video data from the Voyant Imager to display live video image to the connected third-party HD Monitor.
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    K Number
    K181885
    Device Name
    Voyant System
    Manufacturer
    Viseon, Inc.
    Date Cleared
    2018-10-02

    (81 days)

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

    Viseon, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.
    Device Description
    The Voyant System is composed of the Voyant Sheath and Voyant Imager, and Accessories which includes an Image Control Box (ICB) and connecting cables. The Voyant Sheath and Voyant Imager are supplied sterile by ethylene oxide (EtO) while the ICB and connecting cables are supplied non-sterile and are reusable. The Voyant System is used in minimally invasive spine surgery to provide access and visualization of the surgical area of the spine. The Voyant System is a sterile, single-use access and visualization device consisting of a Sheath for access to the spine and an Imager for illumination and visualization of the surgical area. The Sheaths are available in multiple diameters and lengths to accommodate a variety of patient anatomies and spinal surgical procedures. Likewise, the Voyant Imager is available in corresponding diameters to attach to the Voyant Sheath. The Voyant Imager connects to the Image Control Box (ICB) via an HDMI cable and live video image is displayed to a connected external HD monitor in the operating room. The ICB functions to power the Voyant Imager, process video data from the Voyant Imager to display live video image to the connected third-party HD Monitor.
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