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510(k) Data Aggregation
K Number
K140828Device Name
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
Manufacturer
Date Cleared
2015-02-04
(309 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BRAINREADER APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NeuroReader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
Device Description
Neuroreader is a medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from magnetic resonance images. The segmentation system relies on a number of atlases which each consist of a T1-weighted MR image, a binary mask covering the brain and a label map dividing the MR image into different anatomical segments. Neuroreader provides an estimation of the normal volume for a person with similar demographic data. This is done based on a statistical model and a database of healthy material. Neuroreader is intended to automate the current manual process of identifying, labeling and quantifying the volume of brain structures identified on MR images. Neuroreader is aimed to be a support tool for clinicians in assessing structural MRIs. Neuroreader describes the analysis results in a self-explicative volumetric report within an analysis-time of 10 minutes.
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