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510(k) Data Aggregation

    K Number
    K180854
    Device Name
    Voyager Trajectory Array Guide (V-TAG)
    Manufacturer
    Voyager Therapeutics, Inc.
    Date Cleared
    2018-07-23

    (112 days)

    Product Code
    HAW, PRE
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Voyager Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
    Device Description
    The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures in adults. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-guided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.
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