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510(k) Data Aggregation

    K Number
    K111226
    Device Name
    ENDOSCOUT TRACKING SYSTEM
    Date Cleared
    2011-07-01

    (60 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRI-quided interventional procedures. The EndoScout provides in realtime the position (location and orientation) of the device during MR scanning. This data enables the users to guide an interventional procedure to a target inside the body, using minimal invasive approach. Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices (including devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver therapeutic agents like drugs, chemotherapy agents, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
    Device Description
    Not Found
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    K Number
    K033485
    Device Name
    ENDOSCOUT
    Date Cleared
    2004-04-20

    (168 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBIN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRF-guided interventional procedures. The EndoScout provides in real time the position (location and orientation) of the entire device during MR scanning inside the body, using minimal invasive approach. Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices used to destroy tissue, like RF ablation, fasci ablation or cryo-therapy probes, or devices used to deliver various substances (e.g. drugs, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
    Device Description
    Not Found
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