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StrokeViewer Perfusion is an image processing software package intended to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. It is to be used by medical imaging professionals who analyze dynamic perfusion studies, including but not limited to physicians such as neurologists, and radiologists. The software is packed as a Docker container allowing installation on a standard "off-the-shelf" computer or a virtual platform. The software can be used to perform image viewing, processing, and analysis of brain CT perfusion images (CTP) images. Data and images are acquired through DICOM compliant imaging devices. StrokeViewer Perfusion is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time, which are visualized as colored perfusion maps including flow-related parameters and tissue blood volume quantification. Contraindications: - Bolus Quality: absent or inadequate bolus. - Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. . - Presence of hemorrhage .

StrokeViewer Perfusion is an image processing application that runs on a standard "off-the-shelf" computer or a virtual platform, and can be used to perform image processing and analysis of CT perfusion images of the brain. The software can receive, identify and extract DICOM information embedded in the imaging data. The output includes parametric maps related to tissue blood flow (perfusion) and tissue blood volume. Results of the analysis are exported as DICOM series and DICOM reports and can be sent to a preconfigured destination and can be reviewed on a compatible DICOM viewer Perfusion image analysis includes calculation of the following perfusion related parameters: - . Cerebral Blood Flow (CBF) - Cerebral Blood Volume (CBV) - Mean Transit Time (MTT) - Residue function time-to-peak (TMax) . - . Arterial Input Function (AIF) - Volume calculations of affected tissue based on Tmax and CBF abnormalities The device description and overall fundamental scientific technology of the StrokeViewer Perfusion algorithm is equivalent to the predicate device (K182130) in addition to the listed reference devices within this submission.

HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist. HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis. HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image. The intended users of HALO are defined as appropriate medical specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. They include physicians such as neurologists, and/or other emergency department physicians. HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.

HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow. HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation. A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.