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510(k) Data Aggregation
K Number
K202847Device Name
AccuBrain
Manufacturer
Date Cleared
2021-01-15
(112 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BrainNow Medical Technology Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AccuBrain is a fully automated post-processing software that provides automatic labeling, visualization and volumetric quantification of hippocampus from a set of T1W MRIs and returns an analysis report.
Device Description
AccuBrain is a fully automated post-processing software that provides automatic labeling, visualization and volumetric quantification of hippocampus from a set of T1W MRIs and returns an analysis report. The resulting output is a morphometric report in PDF format. The software is suitable for use in both clinical trial research and routine patient care as a support tool for clinicians in assessment of structural MRIs.
AccuBrain provides morphometric measurements based on 3D T1 MRI series. The output of the software includes volumes of hippocampus.
The AccuBrain processing architecture includes an automated internal pipeline that performs artifact correction, segmentation, hippocampus quantification, volume calculation and report generation.
Additionally, automated safety measures include automated quality control functions, such as DICOM check, age check and image resolution check and image quality check.
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