Search Results

GBrain MRI is a post processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on FLAIR MR images in the context of diagnostic radiology. GBrain MRI is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. It is not intended for detection or specific diagnosis of any disease nor for the detection of signal hyperintensities. GBrain MRI should not be used in-lieu of a full evaluation of the patient's MRI scans. The physician retains the ultimate responsibility for making the final patient management and treatment decisions.

GBrain MRI is a non-invasive MR imaging post-processing medical device software that aids in the volumetric quantification of hyperintensities in T2-weighted Fluid Attenuated Inversion Recovery (T2w FLAIR) brain MR images. It is intended to aid the trained radiologist in quantitative measurements. The input to the software is the T2w FLAIR brain MR images. The outputs are volume measurements in Secondary Capture DICOM format, a DICOM Encapsulated pdf file, as well as a DICOM SR. More specifically, the total volume of hyperintensities in the input T2w FLAIR are shown in a new secondary capture image series, called GBrain T2 FLAIR with a segmentation overlay on the hyperintensities that were used to measure the total volumes. These volume measurements are summarized in the DICOM encapsulated pdf and DICOM SR files. The outputs are provided in standard DICOM format that can be displayed on most third-party DICOM workstations and Picture Archive and Communications Systems (PACS). The software is suitable for use in routine patient care as a support tool for radiologists in assessment of structural adult brain MRIs, by providing them with complementary quantitative information. The GBrain MRI processing architecture includes a proprietary automated internal pipeline that performs skull stripping, signal normalization, segmentations, volume calculations, and report generation. From a workflow perspective, GBrain MRI is packaged as a computing appliance that is capable of supporting DICOM file transfer for input, and output of results. The software is designed without the need for a user interface after installation. Any processing errors are reported either in the output series report, or in the system log files. GBrain MRI software is intended to be used by trained personnel only and is to be installed by trained technical personnel. Quantitative reports and derived image data sets are intended to be used as complementary information in the review of a case. The GBrain MRI software does not have any accessories or patient contacting components. The GBrain MRI device is intended to be used for the adult population only.