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The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases.

Rapid MLS software device is a radiological computer-assisted image processing software device using AI/ML. The Rapid MLS device is a non-contrast CT (NCCT) processing module which operates within the integrated Rapid Platform to provide a measurement of the brain midline. The Rapid MLS software analyzes input NCCT images that are provided in DICOM format and provides both a visual output containing a color overlay image displaying the difference between the expected and indicated brain midline at the Foramen of Monro; and a text file output (json format) containing the quantitative measurement.

Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults.

Rapid ANRTN software device is a radiological computer-assisted image processing software device. The Rapid ANRTN device is a CTA processing module which operates within the integrated Rapid Platform to determine the suspicion of head saccular aneurysm(s). The ANRTN software analyzes input CTA images that are provided in DICOM format and provides notification of suspected saccular aneurysm(s) and a non-diagnostic, compressed image for preview. Rapid ANRTN is an AI/ML image processing module which integrates within the Rapid Platform.

Rapid ICH is a radiological computer aided triage and notification software in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (CH). Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, which are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not is a a diagnostic device. The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists are responsible for viewing full images per the standard of care.

Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. The Rapid ICH module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive ICA or MCA-M1 Large Vessel Occlusion (LVO) findings in head CTA images. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO findings. Notifications include compressed preview images. These are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid LVO are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Rapid LVO is a radiological computer-assisted triage and notification software device. The Rapid LVO module is a contrast enhanced CTA module which operates within the integrated Rapid Platform to provide triage and notification of suspected ICA and MCA-M1 Large Vessel Occlusion (LVO) based on the following definitions: ICA Occlusion: A high-grade stenosis or occlusion of the intracranial portion of the ICA. MCA-M1 Occlusion: A high-grade stenosis or occlusion of the horizontal segment of the MCA-M1, defined as the segment which extends from the ICA terminus until the vessel has turned upward into the Sylvian fissure. This includes post-bifurcation M1 segments in some patients. The LVO module uses traditional programming algorithms. The output of the module is a priority notification to clinicians indicating the suspicion of LVO based on positive findings. The Rapid LVO module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams. Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid PETN are intended to be used in conjunction with other patient information and based on ther professional judgment, to assist with trage/proritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

Rapid PETN is a radiological computer-assisted triage and notification software device. The Rapid PETN module is a contrast enhanced CTPA processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected Central Pulmonary Emboli (PE). The PETN module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of central PE based on positive findings. The Rapid PETN module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid LVO are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Rapid LVO 1.0 is a clinical module which operates within the integrated Rapid Platform to provide triage and notification of suspected Large Vessel Occlusion (LVO). The Rapid LVO module consists of the core Rapid Platform software which provides the administration and services for the Rapid image processing modules; and the Rapid LVO module which functions as one of many image processing modules hosted by the platform. Rapid LVO acquires (DICOM compliant) medical image data from CTA scanners through the Rapid Platform interface. The Rapid platform 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), CTA, XA 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 virtual system. It provides viewing, quantification, analysis and reporting capabilities. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making. The basic architecture supports the general functionality to support the Rapid LVO imaging module such as DICOM interfaces, job management, data base functions and communications. The Rapid Platform and base functions are not under review for this submission.

Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.

Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on other clinical factors the clinician may integrate though the Rapid Platform User Interface. The ASPECTS software module processing pipeline performs four major tasks: - Orientation and spatial normalization of the input imaging data (rigid registration/alignment with anatomical template); - Delineation of pre-defined regions of interest on the normalized input data and computing numerical values characterizing underlying voxel values within those regions; - Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and - Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines. Subsequently, the system notifies the physician of the ASPECT score which then requires the confirmation by the physician that a Large Vessel Occlusion (LVO) is detected. The ASPECTS information is then available for the physician to review and edit prior to pushing the data to a PACS or Workstation. The final summary score together with the regions selected and underlying voxel values are then sent to the Picture Archiving and Communication System (PACS) to become a part of the permanent patient medical record.