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510(k) Data Aggregation

    K Number
    K082354
    Device Name
    STEREO NAVIGATOR ACCESSORY, STN-1000
    Date Cleared
    2008-11-18

    (95 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NAVISCAN PET SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stereo Navigator Accessory is an optional accessory to the PEM Flex® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.
    Device Description
    The Stereo Navigator determines the three dimensional coordinates of a userdefined target for an imaged abnormality (e.g. lesion) displayed on the PEM Flex PET Scanner. Since PEM Flex tomographic images are displayed as a series of 2D planar slices, the user must define a target on two orthogonal images to define all three axis coordinates of the target location. These coordinates are processed into stereotactic information by the Stereo Navigator software which is used by the healthcare provider to position a stereotactic frame for guiding the trajectory of an interventional device and for determining the depth to which the interventional device should be inserted along the trajectory. Additionally, the Stereo Navigator provides a means for the user to confirm that localization has been achieved during the interventional procedure and prior to sampling or marking. This is accomplished by placing an encapsulated positronemitting line source (radioactive line source) through the tissue access port (cannula) of the interventional device to the intended sampling or marking site, acquiring an image and comparing the location of the line source relative to the lesion (in at least two orthogonal image planes).
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