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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.

OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. - OnQ Neuro is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. OnQ Neuro is additionally intended to provide automatic fusion of derived parametric maps with anatomical MRI data. OnQ Neuro is intended for use on brain tumors, which are known/confirmed to be pathologically diagnosed cancer. OnQ Neuro is intended for comparison of derived image metrics from multiple time-points. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

OnQ Neuro is a fully automated post-processing medical device software that is used by radiologists, oncologists, and other clinicians to assist with analysis and interpretation of neurological MR images. It accepts DICOM images using supported protocols and performs 1) automatic segmentation and volumetric quantification of brain tumors, which are known/confirmed to be pathologically diagnosed cancer, 2) automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical MR images, and 3) comparison of derived image metrics from multiple time-points. Output of the software provides values as numerical volumes, and images of derived data as grayscale intensity maps and as graphical color overlays on top of the anatomical image. OnQ Neuro output is provided in standard DICOM format as image series and reports that can be displayed on most third-party commercial DICOM workstations. The OnQ Neuro is a stand-alone medical device software package that is designed to be installed in the cloud or within a hospital's IT infrastructure on a server or PC-based workstation. Once installed and configured, the OnQ Neuro software automatically processes images sent from the originating system (MRI scanner or PACS). The software is configured at installation to receive input DICOM files from a network location, and output DICOM to a network destination. 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. OnQ Neuro 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 OnQ Neuro software does not have any accessories or patient contacting components.

Meuro Quant 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 medical device software 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. The resulting output is provided in a standard DICOM format as additional MR series with segmented color overlays and morphometric reports that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS). The high throughput capability makes the software suitable for use in both clinical trial research and routine patient care as a support tool for clinicians in assessment of structural MRIs. NeuroQuant provides morphometric measurements based on 3D T1 MRI series. The output of the software includes volumes that have been annotated with color overlays, with each color representing a particular segmented region, and morphometric reports that provide comparison of measured volumes to age and gender-matched reference percentile data. In addition, the adjunctive use of the T2 FLAIR MR series allows for improved identification of some brain abnormalities such as lesions, which are often associated with T2 FLAIR hyperintensities. The NeuroQuant processing architecture includes a proprietary automated internal pipeline that performs artifact correction, atlas-based segmentation, volume calculation and report generation. Additionally, automated safety measures include automated quality control functions, such as tissue contrast check, atlas alignment check and scan protocol verification, which validate that the imaging protocols adhere to system requirements. From a workflow perspective, NeuroQuant is packaged as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.

NeuroQuant™ 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 segmental brain structures identified on MR images.

NeuroQuant™ Medical Image Processing Software

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.