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510(k) Data Aggregation

    K Number
    K120187
    Device Name
    MULTI-MODALITY IMAGE FUSION
    Manufacturer
    IGT LLC DBA EIGEN
    Date Cleared
    2012-04-06

    (74 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGT LLC DBA EIGEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multi-Modality Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-D and 3-D visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.
    Device Description
    Multi-Modality Image Fusion (MMIF) is software, which comprises of two software components, which is referred to as offline and online. The offline component perfains to the preparation of gland and suspected lesion boundaries on a DICOM image file days or hours prior to the biopsy procedure. The online component fuses the DICOM image files, which were, prepared on the offline component, with a snap shot incoming TRUS image. Each of the two software components can work together or independently.
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