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510(k) Data Aggregation

    K Number
    K180522
    Device Name
    IGTFusion
    Manufacturer
    Date Cleared
    2018-08-16

    (170 days)

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

    IGI Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IGTFusion is a stand-alone software product that provides the physician 3 means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, interventional radiology and other medical Specialties. IGTFusion is not intended for mammography diagnosis.
    Device Description
    The purpose of IGTFusion is to assist the user with the visual evaluation, comparison, and merging of information between anatomical and functional images from a single patient. The user needs to take into consideration the product's limitations and accuracy when integration from the registration results for final interpretation. IGTFusion does not replace the usual procedures for visual comparison of datasets by a user. Fusion images are intended to provide additional information to a user's existing workflow for patient evaluation.
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