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510(k) Data Aggregation

    K Number
    K211529
    Device Name
    NAVIRFA Scope
    Date Cleared
    2022-05-05

    (353 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    NaviFUS Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NAVIRFA Scope is intended to provide physicians with the trajectory information of needle instruments when used in conjunction with medical ultrasound. Instruments used with the NAVIRFA Scope may include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used interventional procedures that already use ultrasound devices for visualization. The device is intended for prescription use only.
    Device Description
    The NAVIRFA Scope utilizes an optical camera and supporting software to integrate the trajectory information of needle instruments towards improving interventional procedures. The NAVIRFA Scope is fixed onto an ultrasonic transducer. The camera observes and detects the motion of a needle with an attached tracking marker (NAVIRFA Tracking Kit). The needle position is calculated and mapped onto a real-time ultrasonic image via NAVIRFA software. The NAVIRFA Scope is compatible with the existing ultrasound system Smartus Ext-1m/3m, TELEMED (K163121).
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