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510(k) Data Aggregation

    K Number
    K163643
    Device Name
    SIRIO H3
    Manufacturer
    Date Cleared
    2017-11-16

    (328 days)

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

    MASMEC SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
    Device Description
    SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures. SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously acquired CT images by means of a semiautomatic algorithm. The system components are: - the patient tool - the needle tool - direction tool - guide for needle - a visualization /elaboration unit - an infrared optical sensor mounted either on the ceiling of the CT room or on the visualization /elaboration unit All the tools in contact both with the skin of the patient and with the surgical instruments are sterile disposable.
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