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510(k) Data Aggregation
K Number
K201948Device Name
AcroDTI Visualizer
Manufacturer
Date Cleared
2020-09-09
(58 days)
Product Code
Regulation Number
892.2050Why 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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