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510(k) Data Aggregation

    K Number
    K082588
    Device Name
    GAMMALOC SYSTEM, MODEL 03-00001
    Manufacturer
    DILON TECHNOLOGIES LLC
    Date Cleared
    2009-12-11

    (459 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    DILON TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GammaLoc System is a lesion localization accessory for the Dilon 6800 Gmma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.
    Device Description
    The GammaLoc System is a lesion localization accessory to the Dilon 6800 Gamma Camera, previously cleared under K984466 (originally named Dilon 2000 Digital Gamma Camera). The Dilon Gamma Camera is a high resolution, small field of view, portable gamma camera for use in imaging radiopharmaceuticals consisting of three primary components: the detector head, the gantry arm and the mobile cabinet. There are no changes to the gamma camera in this submission.
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