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510(k) Data Aggregation

    K Number
    K181706
    Device Name
    neuromate Gen III
    Date Cleared
    2018-07-26

    (28 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renishaw Mayfield Sarl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. neuromate Gen III has been validated with the following stereotactic frames: - 1 the Leksell Type G comprising of head frame and CT Localizer, - 2 the CRW HRAIM with the BRWLF localizer. - 3 the CRW UCHRA with the Luminant and BRWLF localizers
    Device Description
    Not Found
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    K Number
    K180206
    Device Name
    neuromate Gen III
    Date Cleared
    2018-04-24

    (90 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Renishaw Mayfield Sarl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
    Device Description
    A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
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    K Number
    K132755
    Device Name
    NEUROMATE FRAMELESS GEN II
    Date Cleared
    2014-04-29

    (238 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENISHAW MAYFIELD SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
    Device Description
    A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
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