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510(k) Data Aggregation

    K Number
    K231141
    Device Name
    STarFix Designer Software C0265
    Manufacturer
    FHC, Inc.
    Date Cleared
    2023-09-08

    (140 days)

    Product Code
    QRI, HAW
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    QRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
    Device Description
    FHC, Inc. STarFix™ Designer software is an advanced image-based neurosurgical planning software application designed for generating patient specific frames (FHC, Platform) primarily for Deep Brain Stimulation (DBS) Proedures and stereo-electroencephalography (SEEG) by means of the WayPoint™ Stereotactic platforms. The STarFix™ Designer offers the following core features: - Image import and registration - Open and manipulate CT and MR images for surgical planning - . Rigid registration between CT and MR images, with user-selected reference scan of either modality. - Automatic localizer extraction - Extract localizers from preoperative CT manually or automatically - I Manually place localizers on MR scans - Manual refinement of localizer position - Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP - Trajectory planning ● ● - DBS STarFix™ Platform frame modeling ● - . Multi-Oblique STarFix™ Platform frame modeling - . Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery - Save the plan any time during the planning session The STarFix™ Designer provides a modern design, built to ease user interaction, and allow fast and efficient planning for the WayPoint™ Platforms and ultimately, the implantation of DBS electrodes. With safety as a primary concern, all planning elements need to be verified and marked explicitly before a platform model can be built. The user interface is guiding the necessary planning steps, by using numbered menus and intuitive labeling, along with a minimum of application settings and common actions arranged in the form of a toolbar dedicated to either 2D or 3D operations.
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