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510(k) Data Aggregation

    K Number
    K211039
    Device Name
    BIT-Motion
    Date Cleared
    2021-12-15

    (252 days)

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

    DDE MRI Solutions LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BIT-Motion is a stand-alone image post processing software. The Bit-Motion is intended for use as a PACS device, which is interfaced to the clinics' LAN. It receives clinical studies from hospital modalities, processes functional volumetric data and generates parametric maps that display changes intensity. It also includes manual display manipulation, annotation and control tools, which assist professional users to evaluate the displayed maps and to transfer the results to the PACS, in DICOM format. The BIT-Motion indications for use are receiving breast studies from MRI scanners and processing them to generate DTI (Diffusion Tensor Imaging) 2D and 3D parametric maps that display changes in the values of water diffusion coefficients and directions, as well as in indices defining diffusion anisotropy. The device-displayed DTI parametric maps are evaluated by the users. The device is indicated for use by trained radiologists and may provide information on breast water diffusion features. The BIT-Motion should not be used in isolation breast tissue features or for making patient management decisions.
    Device Description
    The BIT-Motion is a software package that is aimed to process MRI images. The software runs on a PC server, which is connected to the Local Area Network (LAN). The device receives MRI datasets from MRI scanner over the network in DICOM format, processes the images and transfers the outcome images in DICOM format, to selected PCAS stations.
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