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510(k) Data Aggregation

    K Number
    K201948
    Device Name
    AcroDTI Visualizer
    Manufacturer
    Date Cleared
    2020-09-09

    (58 days)

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

    AcroViz Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.
    Device Description
    AcroDTI Visualizer is a software for processing and viewing Diffusion Tensor Imaging (DTI) from dataset of Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to adjust the image brightness and contrast to assist visual evaluation. AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).
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