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Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT). Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: · Bolus Quality: absent or inadequate bolus. · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. · Presence of hemorrhage. · C-Arm CTP is not to be used in the Rapid Thrombectomy indication criteria, other modalities should be consulted. Cautions: · C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities. Rapid works with the following types of (DICOM compliant) medical image data: - CT (Computed Tomography) - MRI(Magnetic Image Resonance) ● Rapid acquires (DICOM compliant) medical image data from the following sources: - . DICOM file - DICOM CD-R ● - Network using DICOM protocol. ● Rapid provides tools for performing the following types of analysis: - selection of acute stroke patients for endovascular thrombectomy ● - volumetry of thresholded maps - time intensity plots for dynamic time courses - measurement of mismatch between labeled volumes on co-registered image ● volumes - large vessel density. ● Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server. Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT [NCCT, CT, CTA, C-arm CT(CBCT)] or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data, Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid Platform is a central unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today: - Rapid CTP/MRP/C-arm CTP, DWI, Dynamic Analysis (Original: K121447, Updated ● with K172477, K182130, K213165, K233512 and K233582) - Rapid CTA (K172477) ● - Rapid ASPECTS (K200760, K232156) - Rapid ICH (K193087, K221456) - Rapid LVO (K200941, K221248) - Rapid NCCT Stroke (K222884) - . Rapid RV/LV (K223396) - Rapid PETN (K220499) - Rapid ANRTN (K230074) ● - Rapid SDH (K232436) ● The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

The Rapid RV/LV software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements for adults. Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles. The Rapid RV/LV device provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Rapid RV/LV software device is a radiological computer-assisted image processing software device. The Rapid RV/LV device is a CTPA processing module which operates within the integrated Rapid Platform to locate and measure the right and left ventricle diameters of the human heart to ultimately provide a ratio of the right ventricle diameter to the left ventricle diameter. The RV/LV software analyzes input CTPA images that are provided in DICOM format and provides both a visual output containing a color overlay image displaying where the ventricle diameter measurements were made along with the quantitative results of the measurements and a text file output (json format) containing the quantitative measurement results (the individual right and left ventricle diameters and their corresponding ratio).

Rapid 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 as VMware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion can be used by physicians to aid in the selection of acute patients (with known ocuusion of the intracranial internal carotid artery or proximal middle cerebral artery) Instructions for the use of contrast agents for this in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: - Bolus Quality: absent or inadequate bolus. - Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate . - . Presence of hemorrhage

Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities. Rapid works with the following types of (DICOM compliant) medical image data: - CT (Computed Tomography) ● - MRI(Magnetic Image Resonance) Rapid acquires (DICOM compliant) medical image data from the following sources: - . DICOM file - DICOM CD-R - Network using DICOM protocol ● Rapid provides tools for performing the following types of analysis: - selection of acute stroke patients for endovascular thrombectomy ● - volumetry of thresholded maps - time intensity plots for dynamic time courses ● - measurement of mismatch between labeled volumes on co-registered image ● volumes - large vessel density Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server. Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT (NCCT. CT, CTA) or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data, Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today: - Rapid CTP/MRP, DWI, Dynamic Analysis (Original: K121447, Updated with K172477; ● and K182130): - Rapid CTA (K172477); ● - Rapid ASPECTS(K190395); ● - Rapid ICH (K193087); - . Rapid LVO (K200941); The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).