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510(k) Data Aggregation

    K Number
    K110971
    Device Name
    TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
    Manufacturer
    NAVOTEK MEDICAL LTD
    Date Cleared
    2012-01-10

    (279 days)

    Product Code
    IYE, NEU
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAVOTEK MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tracer Implantation Kit is indicated for use to radiographically and radioactively mark soft tissue for future therapeutic procedures. The Tracer is indicated for permanent implantation in the prostate. The Tracer is intended to be used in conjunction with the RealEye system as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The IndeX Implantation Kit is indicated for use to radiographically mark soft tissue for future therapeutic procedures. The IndeX is intended to be used as a radiographic fiducial marker for visualization using x-ray, CT, or Cone Beam CT.
    Device Description
    The Tracer is a Platinum/Iridium radioactive soft tissue fiducial for implantation in the prostate, in or near the treatment target for radiotherapy treatments. The Tracer emits photons that enable its localization by the Navotek RealEye system that is designed to track localized gamma-emitting radioactive sources. The implantation of the Tracer is performed using an Implantation Device, which is supplied with the Tracer pre-loaded within it. Therefore, the Tracer is supplied as a 'Tracer Implantation Kit' which includes the Tracer and the Implantation Device. The Tracer lmplantation Kit is provided in a single package, sterile (by gamma radiation) and ready for use. It is intended for single use only. The IndeX is identical to the Tracer in all respects except that it is not radioactive. It is intended for use to radiographically mark soft tissue and to be visible in x-ray, CT, and Cone Beam CT images.
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    K Number
    K100625
    Device Name
    REALEYE MODEL VCPS
    Manufacturer
    NAVOTEK MEDICAL LTD
    Date Cleared
    2011-01-21

    (323 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAVOTEK MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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