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Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - overriding artery - septal defect at the cardiac crux - abnormal relationship of the outflow tracts - enlarged cardiothoracic ratio - right ventricular to left ventricular size discrepancy - tricuspid valve to mitral valve annular size discrepancy - pulmonary valve to aortic valve annular size discrepancy - cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.

Sonio Suspect is a Software as a Service (SaaS) solution that aims at helping interpreting physicians (designated as healthcare professionals i.e. HCP in the following) to identify abnormal fetal ultrasound findings during and/or after fetal ultrasound examinations. Sonio Suspect is a web application accessible from any device connected to the internet. It can be accessed on a tablet, computer or any other support capable of providing access to a web application. Sonio Suspect can be used by HCPs as a concurrent reading aid on acquired images, to assist them during and/or after fetal ultrasound examinations of gestational age (GA): from 11 weeks to 41 weeks. A concurrent read by the users means a read in which the device output is available during and/or after the fetal ultrasound examination. The way Sonio Suspect is built allows the HCP to use it at any moment. The software can process any Ultrasound image file uploaded by the HCP, at any time. Sonio Suspect can be connected through API to external devices (as an ultrasound machine) to receive images. Sonio Suspect workflow goes through the following steps: As soon as an image is automatically received, it is automatically detected and associated with a view (and can be manually re-associated by the HCP). Then abnormal fetal ultrasound findings linked to the view are evaluated and displayed, individually, with one of the following status: - Suspected (abnormal findings identified on the image); - . Not Suspected (abnormal findings not identified on the image); - . Can't be analyzed (abnormal findings not evaluated due to one or several structures not detected or if the fetal position selected is "other or unknown" while it's required to evaluate the abnormal finding). Each abnormal finding status can be manually overridden to Present or Not Present by the user.

Brainomix 360 e-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 uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score. Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well). Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score. Limitations: 1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care. 3. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years. 4. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. 5. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners. Contraindications/ Exclusions/Cautions: · Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. · Hemorrhagic Transformation, Hematoma.

Brainomix 360 e-ASPECTS (also referred to as e-ASPECTS in this submission) is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. Brainomix 360 e-ASPECTS allows for the visualization, analysis and post-processing of DICOM compliant Non-contrast CT (NCCT) images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making. Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from 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 the clinician's judgment. Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing. Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-ASPECTS software (e.g. a LAN connection). Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through a mobile application or via e-mail. Brainomix 360 e-ASPECTS email notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. Brainomix 360 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences. Once received, image processing is automatically applied. Once any image processing has been completed, notifications are sent to pre-configured users to inform that the image processing results are ready. Users can then access and review the results and images via the web user interface case viewer or PACS viewer. The core of e-ASPECTS algorithm (excluding image loading or result output format) can be summarised in the following 3 key steps of the processing pipeline: - Pre-processing: brain extraction from the three dimensional (3D) non-enhanced contrast CT head dataset and its reorientation/normalization by 3D spatial registration to a standard template space. - Delineation of the 20 (10 for each cerebral hemisphere) pre-defined ASPECTS regions of interest on the normalized 3D image. - Image feature extraction and heatmap generation which consists of the computation of numerical values characterizing brain tissue, apply a trained predictive model to those features and generate a 3D heatmap from the models output for highlighting regions contributing towards the ASPECTS score. The Brainomix 360 e-ASPECTS module is made available to the user through the Brainomix 360 platform. The Brainomix 360 platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today: - Brainomix 360 e-ASPECTS (K221564) (predicate device) - Brainomix 360 e-CTA (K192692) - Brainomix 360 e-CTP (K223555) - Brainomix 360 e-MRI (K231656) - Brainomix 360 Triage ICH (K231195) - Brainomix 360 Triage LVO (K231837) - Brainomix 360 Triage Stroke (K232496)

Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS software may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Koios DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: · Patient management decisions should not be made solely on the results of the Koios DS analysis. · Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. · Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. · The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.

Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.

Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - overriding artery - septal defect at the cardiac crux - abnormal relationship of the outflow tracts - enlarged cardiothoracic ratio - right ventricular to left ventricular size discrepancy - tricuspid valve to mitral valve annular size discrepancy - pulmonary valve to aortic valve annular size discrepancy - cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis. EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized AS clinical practice quidelines. Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery

EchoSolv AS is a standalone, cloud-based decision support software which is intended to be used certified cardiologist to aid in the diagnosis of Severe Aortic Stenosis. EchoSolv AS analyzes basic patient demographic data and measurements obtained from a transthoracic echo examination to provide a categorical assessment as to whether the data are suggestive of a high, medium or low probability of Severe AS. EchoSolv AS is intended for patients who 18 years or older who have an echocardiogram performed as part of routine clinical care (i.e., for the evaluation of structural heart disease). Patient demographic and echo measurement data is automatically processed through the artificial intelligence algorithm which provides an output regarding the probability of a Severe AS phenotype to aid in the clinical diagnosis of Severe AS during the review of the patient echo study and generation of the final study report, according to current clinical practice guidelines. The software provides an output on the following assessments: 1. Severe AS Phenotype Probability Whether the patient has a high, medium, or low probability of exhibiting a Severe AS phenotype, based on analysis by the EchoSolv AS proprietary Al algorithm, that the determined predicted AVA is ≤1.0cm². The Al probability score requires a minimum set of data inputs to provide a valid output but is based on all available echocardiographic measurement data and does not rely on the traditional LVOT measurements used to in the continuity equation. 2. Severe AS Guideline Assessment Whether the patient meets the definition for Severe AS based on direct evaluation of provided echocardiogram data measurements (AV Peak Velocity, AV Mean Gradient and AV Area) with current clinical practice guidelines (2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease). EchoSolv AS is intended to be used by board-certified cardiologists who review echocardiograms during the evaluation and diagnosis of structural heart disease, namely aortic stenosis. EchoSolv AS is intended to be used in conjunction with current clinical practices and workflows to improve the identification of Severe AS cases.

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone reporting software to assist trained medical professionals in analyzing thyroid ultrasound images of adult (>=22 years old) patients who have been referred for an ultrasound examination. Output of the device includes regions of interest (ROIs) placed on the thyroid ultrasound images assisting healthcare professionals to localize nodules in thyroid studies. The device also outputs ultrasonographic lexicon-based descriptors based on ACR TI-RADS. The software generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. SMART-T may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report. Patient management decisions should not be made solely on the basis of analysis by See-Mode Augmented Reporting Tool, Thyroid.

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone, web-based image processing and reporting software for localization, characterization and reporting of thyroid ultrasound images. The software analyzes thyroid ultrasound images and uses machine learning algorithms to extract specific information. The algorithms can identify and localize suspicious soft tissue nodules and also generate lexicon-based descriptors, which are classified according to ACR TI-RADS (composition, echogenicity, shape, margin, and echogenic foci) with a calculated TI-RADS level according to the ACR TI-RADS chart. SMART-T may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report. The software then generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. Any information within this report can be changed and modified by the clinician if needed during quality control and before finalizing the report. The software runs on a standard "off-the-shelf" computer and can be accessed within the client web browser to perform the reporting of ultrasound images. Input data and images for the software are acquired through DICOM-compliant ultrasound imaging devices.

AISAP CARDIO V1.0 is a software platform that automatically processes and analyzes acquired cardiac POCUS images, producing a report with diagnostic assessment and measurements of several key cardiac structural and functional parameters, including: presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves and aortic stenosis), and measurements of the Left Ventricle Ejection Fraction (LVEF), right and left ventricular dimensions, right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter. The device outputs are provided in a report that is intended to support qualified physicians in their analysis and interpretation of adult cardiac POCUS images, using FDA-cleared ultrasound devices. Physicians should be trained and privileged by their organization following education processes and should perform cardiac POCUS according to their specialty professional society clinical guidelines. AISAP CARDIO V1.0 has not been validated for the assessment of congenital heart disease, and/or intra-cardiac lesions (e.g., tumors, thrombi, vegetations), prosthetic valves, and in the presence of ventricular assist devices. AISAP CARDIO V1.0 is indicated for use in adult patients only.

AISAP CARDIO V1.0 is a machine learning-based decision support software device, indicated as an adjunct to diagnostic Cardiac point of care ultrasound (C-POCUS) for adult patients undergoing assessment for cardiac disease. This device performs automated analysis of ultrasound images and generates valvular assessments and measurements of standard cardiac structural and functional parameters. - 1. Inform the user of a suspected cardiac valvular regurgitation (mitral, tricuspid, or aortic), and/or aortic stenosis is: either greater than mild severity or none to mild severity. - 2. Inform the user of the 4 class American Society of Echocardiography (ASE) recommended category for valvular regurgitation (mitral, tricuspid, or aortic), and or aortic stenosis. Each finding categorizes according to none, mild, moderate, or severe. - 3. Measurements of the following standard cardiac structural or functional parameters: - Left Ventricular Ejection Fraction (LVEF) (percent) a. - Left ventricular end diastolic diameter (cm) b. - Right ventricular area change (RV FAC [ratio]) C. - Inferior vena cava (IVC) maximal diameter (mm) d. - e. Aortic root diameter (cm) - ਿ Right atrium (RA) area (cm2) - Left atrium (LA) area (cm²) g. AISAP CARDIO V1.0 assists the physician in assessing 4 major valvular findings in adults, along with providing information on several correlated cardiac ultrasound measurements frequently found to be abnormal in association with valvular heart disease. Used together and interpreted by the physician, the device provides information that may assist in rendering an accurate diagnosis of selected cardiac findings. AISAP CARDIO V1.0 is adjunctive to cardiac POCUS (C-POCUS) use by privileged physicians in use scenarios supported by clinical guidelines. Specifically, patient management decisions are not intended to be and should not be made solely on the results of the software analysis of the proposed device. When significant valve pathology is suspected comprehensive echocardiography should be considered in accordance with the relevant professional guidelines. AISAP CARDIO V1.0 uses machine learning NN (neural network) models trained to recognize patterns and make decisions. AISAP CARDIO V1.0 contains classification models which identify categories within data, regression models which predict numerical values, and instance segmentation models that detect and segment objects within images.

CINA-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 reorients images, segments and analyzes ASPECTS Regions of Interest (ROIs). CINA-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. CINA-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 (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring. Limitations: 1. CINA-ASPECT is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. CINA-ASPECT has been validated in patients with known MCA or ICA unilateral occlusion prior to ASPECTS scoring. 3. CINA-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumors or abscesses, traumatic brain injuries, hemorrhagic transformation and hematoma. 4. Use of CINA-ASPECT in clinical settings other than brain ischemia within 12 hours from time last known well, caused by known ICA or MCA occlusions has not been tested. 5. CINA-ASPECTS has only been validated and is intended to be used in patient populations aged over 21. 6. CINA-ASPECTS has been validated and is intended to be used with images acquired with Canon Medical Systems Corporation, GE Healthcare, Philips Healthcare and Siemens Healthineers scanners. Contraindications/Exclusions/Cautions: - Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. - Important streak artifacts and noisy images: Presence of important streak artifact and significant noise within the NCCT images that make the scan technically inadequate. - Hemorrhagic Transformation, Hematoma.

CINA-ASPECTS is a standalone computer-aided diagnosis (CADx) software that processes noncontrast head CT (NCCT). CINA-ASPECTS is a standalone executable program that may be run directly from the commandline or through integration, deployment and use with medical image communications devices. The software does not interface directly with any CT scanner or data collection equipment; instead, the software receives non-contrast head CT (NCCT) scans identified by medical image communications devices, processes them using algorithmic methods involving execution of multiple computational steps to provide 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 and overlaid onto brain scan images. 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 the clinician's judgment. Series are processed by running the CINA-ASPECTS Image Processing Applications on noncontrast head CT images (NCCT) to perform the: - Reorientation, tilt-correction of the input imaging data; - Delineation of predefined regions of interest on the corrected input data and computing numerical values characterizing underlying voxel values within those regions; - Visualizing the voxels which have contributed to the ASPECTS score (also referred to as a 'heat map'); and - Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines. The CINA-ASPECTS User Interface Agent provides the ASPECTS information to the clinician to review and edit. It also requires the confirmation by a clinician that a Large Vessel Occlusion (LVO) is detected. This confirmation is used by the CINA-ASPECTS to limit the detection of areas of early ischemic changes to the infarcted brain hemisphere selected by the user. The final summary score together with the regions selected and underlying voxel values are then stored in DICOM format to be transferred by the medical image communications device for output to a Picture Archiving and Communication System (PACS) or workstation. The CINA-ASPECTS device is made of two components: - The CINA-ASPECTS image processing application which reads the input file and generates an automatic ASPECT score and the applications outputs - A CINA-ASPECTS UI Agent which provides the ASPECTS information to the clinician to review and edit for final archiving.

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 adult patients presenting for diagnostic imaging workup, 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 for ischemic stroke patient (typically < 24 hours since last known well) during image interpretation following the standard of care. 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 presents the original and annotated images for concurrent reads.

The Rapid platform is Software as a Medical Device (SaMD), which provides for the visualization and study of changes in tissue and vasculature using digital images captured by diagnostic imaging systems including CT (Computed Tomography), CTA (CT Angiography), MRI (Magnetic Resonance Imaging) and MRA (MR Angiography) 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. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making. 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 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 availability of the ASPECT Score with an overlayed atlas. The ASPECTS information is then available for the physician to review and edit prior to sending 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.