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NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile data.

NeuroQuant is a fully automated MR imaging post-processing software medical device that provides automatic labeling, visualization, and volumetric quantification of brain structures and lesions from a set of MR images and returns segmented images and morphometric reports. NeuroQuant provides morphometric measurements of brain structures based on a 3D T1 MRI series. The optional use of the T2 FLAIR MR series and T2* GRE/SWI series allows for additional quantification of T2 FLAIR hyperintense lesions and T2* GRE/SWI hypointense lesions. The device is used by medical professionals in imaging centers, hospitals, and other healthcare facilities as well as by clinical researchers. When used clinically, the output must be reviewed by a radiologist or neuroradiologist. The results are typically forwarded to the referring physician, most commonly a neurologist. The device is a "Prescription Device" and is not intended to be used by patients or other untrained individuals. From a workflow perspective, the device is packaged as a computing appliance that is capable of supporting DICOM standard input and output. NeuroQuant supports data from all major MRI manufacturers and a variety of field strengths. For best results, scans should be acquired using specified protocols provided by CorTechs Labs. As part of processing, the data is corrected by NeuroQuant for image acquisition artifacts, including gradient nonlinearities and bias field inhomogeneity, to improve overall image quality. Next, image baseline intensity levels for gray and white matter are identified and corrected for scanner variability. The scan is then aligned with the internal anatomical atlas by a series of transformations. Probabilistic methods and neural network models are then used to label each voxel with an anatomical structure based on location and signal intensities. Output of the software provides values as numerical volumes, and images of derived data as grayscale intensity maps and as color overlays on top of the anatomical image. The outputs are provided in standard DICOM format as image series and reports that can be displayed on many commercial DICOM workstations. The software is designed without the need for a user interface after installation. Any processing errors are reported either in the output series error report or system log files. The software can provide data on age and gender-matched normative percentiles. The default reference percentile data for NeuroQuant comprises normal population data. The device provides DICOM Storage capabilities to receive MRI series in DICOM format from an external source, such as an MRI scanner or PACS server. The device provides transient data storage only. If additional scans from other time points are available, the software can perform change analysis.

AutoAlign™ Atlas-Based Image Registration software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent anatomic orientation, a process known as image registration. AutoAlign™ Atlas-Based Image Registration software is intended to be marketed as a software device that can provide improvements to the manual processes of image registration. The dominant use of AutoAlign™ Atlas-Based Image Registration software is its integration into proprietary MR image software packages by MRI scanner manufacturers to allow users to generate consistent patient image registrations for image acquisition, a process otherwise known as AutoSlice Prescriptioning.

AutoAlign™ Atlas-Based Image Registration software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent anatomic orientation, a process known as image registration. AutoAlign™ Atlas-Based Image Registration software is intended to be marketed as a software device that can provide improvements to the manual processes of image registration. The dominant use of AutoAlign™ Atlas-Based Image Registration software is its integration into proprietary MR image software packages by MRI scanner manufacturers to allow users to generate consistent patient image registrations for image acquisition, a process otherwise known as AutoSlice Prescriptioning. AutoAlign™ Atlas-Based Image Registration has a feedback mechanism which measures and reports alignments which have the potential to be outside of stated specifications. This is reflected in as a "Measurement Index" value which is the average of the Mahalanobis distance for the voxel intensity of all atlas points to the patient images supplied for alignment.

AutoAlign software is intended to provide an output registration matrix that may be utilized to align an MRI brain scan to a known and consistent 3-dimensional (3-D) atlas of the human brain. AutoAlign software will be marketed as a software device that can provide improvements to the manual processes of MRI brain image registration. To be utilized for the registration of brain images for MRI.

The device (software) operates by comparing a subjects' brain MR localizer images to a preexisting atlas of the human brain. The software then calculates a set of coordinates that can be used to align subsequent MRI images to the atlas. The accuracy of the alignment is measured and then programmatically reported. AutoAlign is a software device that provides the following features: - . Imports MRI brain images - Calculates and then outputs an optimized 3-D registration matrix that permits . alignment of the brain, regardless of the actual physical position of the subject's head in the image. For instance, in the test alignment: - o in the sagittal image, the intra-hemispheric plane is at the center slice of the MRI volume so the anterior & posterior commeasures (ac-pc line) are visible on that slice. - in the axial image, the intra-hemispheric plane is parallel to the Y axis. o - in the coronal image, the intra-hemispheric plane is parallel to the Y axis. o - It can provide consistent scan/rescan alignment between separate scanning ● sessions within boundaries established and documented in Product Labeling Instructions. - This software can be utilized by a MRI scanner original equipment manufacturer ● (OEM) to improve the workflow and automation of MRI brain study acquisitions. - AutoAlign does not alter or otherwise modify the initial MR localizer image in any way - The AutoAlign system does not have any adverse affects on health. This tool ● operates as a stand-alone software device, receives the MR scout localizer as input and outputs an optional registration prescription. AutoAlign does not alter or otherwise modify the initial MR localizer image in any way, and Labeling stipulates a review of the output registration by a trained MR operator.

Deep Gray is intended to measure the volume of any brain structure and tissue from a set of MR images. It provides visualization tools, basic and advanced regions of interest drawing features and volumetric quantification. Deep Gray is to be used by trained physicians. Visualization/Processing/Analysis of brain images from MR scanners.

Deep Gray is a software device that provides the following features: - Import of MR brain images (DICOM 3.0 format). - Multi-frame and multi-orientation image display. - Basic regions of interest drawing tools: free hand drawing, filled polygon . drawing. Labels can be associated with drawn objects. - Advanced drawing tool: semi-automatic labeling of normal brain structures and . tissues. - . Generation of a report listing the volumes of labeled structures and tissues. The operator can choose to manually draw and label brain structures and tissues, or they can chose to perform a semi-automatic labeling, followed by visual inspection and manual adjustment. The Deep Gray system does not have any adverse affects on health. This tool measures and displays the volume of regions of interest. The operator can choose to accept, modify, or reject the volume and/or label suggested by the program.