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510(k) Data Aggregation

    K Number
    K162314
    Device Name
    IMACTIS CT-Navigation system
    Manufacturer
    Date Cleared
    2018-04-24

    (614 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMACTIS, SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space. The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where is currently used for visualizing such procedures. The system is not intended for guidance for the head, nervous system and central circulatory system (heart included).
    Device Description
    The IMACTIS® CT-NAVIGATION system consists of a navigation station, specific software and a dedicated instrumentation set used in an interventional radiology room during percutaneous interventional radiological procedures performed under Computed Tomography.
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