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510(k) Data Aggregation

    K Number
    K141514
    Device Name
    SYNAPSE 3D TENSOR ANALYSIS
    Manufacturer
    FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC.
    Date Cleared
    2014-09-03

    (86 days)

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

    FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning. Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.
    Device Description
    Synapse 3D Tensor Analysis is an optional software module that works with Synapse 3D Base Tools, cleared by CDRH via K120361 on 04/06/2012. Synapse 3D Tensor Analysis, Synapse 3D Base Tools and other optional software modules consist of the Synapse 3D product family. Synapse 3D is medical application software running on a Standalone PC or Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers provides custom workflows, UI, and reporting functions for trained medical professionals to aid them in reading, interpreting, reporting, screening and treatment planning. Synapse 3D Tensor Analysis supports the display of diffusion and Fractional anisotropy (FA) colormap images, white matter tractography, dynamic review, vessel and body visualization with registration of MR, CT, XA, PET and NM. Tensor Analysis tool enables tensor analysis from diffusion-weighted MR images and tractography-based extraction and observation of local water diffusion properties and directional dependence of the diffusion in the white matter. Additional images (mainly CT images) can be loaded, and skin, bone, brain parenchyma, tumor, and cerebral vessels can be extracted in craniotomy simulations. The main functions are shown below. - Display FA and diffusion colormap images - Extract and observe white matter - Calculate FA value, number of fibers, area, and volume in the specified ROI - Simultaneous display of white matter and skin, bone, brain parenchyma, tumor, artery, vein, and other reqions - Craniotomy simulations involving cutting of skin and bone regions, brain surface clipping by depth, and tumor plane clipping
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