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icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria.

icobrain aria is a software-only device for assisting radiologists with the detection of amyloid-related imaging abnormalities (ARIA) on brain MRI scans of Alzheimer's disease patients under an amyloid beta-directed antibody therapy. The device utilizes 2D fluid-attenuated inversion recovery (FLAR) for the detection of ARIA-E (edema/sulcal effusion) and 2D T2* gradient echo (T2*-GRE) for the detection of ARIA-H (hemosiderin deposition). icobrain aria automatically processes input brain MRI scans in DICOM format from two time points and generates annotated DICOM images and an electronic report.

icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices. icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.

The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.

icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT 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 or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long.

icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT 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 or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. - icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. - icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long. The input images can be MR images (current icobrain software - KI6I 148 and KI80326) or CT images (current icobrain software - K181939). During the pre-processing, each scan is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the measurements of the brain structures and abnormalities. Finally, the computed measurements are summarized into an electronic report and (some) segmentations are overlaid on the input images.

icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT 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 or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long.

The input images can be MR images (current icobrain software - K161148 and K180326) or CT images. During the pre-processing, the modality and/or sequence of each scan is detected and each scan is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the measurements of the brain structures and abnormalities. Finally, the computed measurements are summarized into an electronic report and (some) segmentations are overlaid on the input images, generating output images in DICOM format. Since the processing of MR images remains unchanged compared to the currently approved icobrain software (see KI 6 I 148 and K180326), the remainder of this file will focus on the design of the software that processes CT images. We refer to the overall architecture focused on (pre)processing CT images as the CT pipeline.

icobrain 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. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide volumes from images acquired at a single timepoint icobrain long is intended to provide changes in volumes between two images that were acquired on the samer, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain cross cannot be compared with the results of icobrain long.

icobrain 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. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. - icobrain cross is intended to provide volumes from images acquired at a single timepoint - · icobrain long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain cross cannot be compared with the results of icobrain long. As input, icobrain uses TI-weighted and a fluid-attenuated inversion recovery (FLAIR) DICOM MR images from a single or from multiple time points. In case of multiple time points, i.e. multiple MRI scans from the same subject, for each time point one FLAIR and one TI image are used as input. During the pre-processing, the scan type (TI, FLAIR) is detected for every input image before it is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the volumes of the brain structures. In case MRI scans from the same subject on multiple time points are available, the changes in volume of the brain structures are calculated as well. Finally, the computed volumes and volume changes (in case of multiple time points) are summarized into an electronic report and (some) segmentations are overlaid on the input images.

icobrain 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. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. Icobrain cross is intended to provide volumes from images acquired at a single timepoint icobrain long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain cross cannot be compared with the results of icobrain long.

icobrain 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. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. - icobrain cross is intended to provide volumes from images acquired at a single timepoint - icobrain long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints The results of icobrain cross cannot be compared with the results of icobrain long. As input, icobrain uses TI-weighted and fluid-attenuated inversion recovery (FLAIR) DICOM MR images from a single or from multiple time points. In case of multiple time points, i.e. multiple MRI scans from the same subject, for each time point one FLAIR and one TI image are used as input. During the pre-processing, the scan type (TI, FLAIR) is detected for every input image before it is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the volumes of the brain structures. In case MRI scans subject on multiple time points are available, the changes in volume of the brain structures are calculated as well. Finally, the computed volumes and volume changes (in case of multiple time points) are summarized into an electronic report and (some) segmentations are overlaid on the input images. The software displays the following volumetric measures: - normalized volume and volume changes of the whole brain (sum of white and grey matter), - normalized volume and volume changes of grey matter, - unnormalized volume and volume changes of FLAIR white matter hyperintensities. Normalized whole brain and grey matter volumes are corrected for head size and are compared to a healthy population using a statistical model. The reported FLAIR white matter hyperintensities volumes are not normalized since they are not comparable to a reference population.