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CINA-CSpine is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and appropriately trained physician specialists by flagging and communication of suspected positive findings compatible with acute cervical spine fractures including non-displaced fracture lines and/or displaced fracture fragments. CINA-CSpine uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device is not designed to detect vertebral compression fractures. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that 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 it is not intended to be used as a diagnostic device. The results of CINA-CSpine 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 ultimately responsible for reviewing full images per the standard of care.

CINA-CSpine is a radiological computer-assisted triage and notification software device. CINA-CSpine runs on a standard "off the shelf" server/workstation and consists of CSpine Image Processing Application, which can be integrated, deployed and used with the CINA Platform (cleared under K200855) or other medical image communications devices. CINA-CSpine receives cervical spine CT scans identified by the CINA Platform or other medical image communications device, processes them using deep learning algorithms involving execution of multiple computational steps to identify the suspected positive findings compatible with acute cervical spine fractures and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or workstation for worklist prioritization. To identify the suspected presence of cervical fractures, the device uses a deep learning model trained end-to-end on 1,338 cases acquired from US and France, representing a distribution of fracture presentations, locations and acquisition protocols, including multiple scanner models from Siemens, Philips, GE and Canon/Toshiba. Additional deep learning models are used to locate the individual vertebrae to exclude images that do not conform to the expected field of view. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a cervical spine fracture, then active notifications on the flagged series are sent to the worklist application. The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the cervical spine CT studies which include at least 5 visible cervical vertebrae received by CINA-CSpine device are displayed in the worklist and those on which the algorithms have detected a suspected finding are marked with an icon (i.e., active notification). In addition, a compressed, grayscale, unannotated image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for diagnostic use beyond notification. Presenting the trained physician specialist with notification facilitates earlier triage by allowing image prioritization in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone. The CINA platform is an example of medical image communications platform for integrating and deploying the CINA-CSpine image processing application. The medical image communications device (i.e., the technical platform) provides the necessary requirements for interoperability based on the standardized DICOM protocol and services to communicate with existing systems in the hospital radiology department such as CT modalities or other DICOM nodes (DICOM router or PACS for example). It is responsible for transferring, converting formats, notifying of suspected findings and displaying medical device data such as radiological data. The medical image communications server includes the Worklist client application, which receives notifications from the CINA-CSpine Image Processing application.

CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings. CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-VCF 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 ultimately responsible for reviewing full images per the standard of care.

CINA-VCF is a radiological computer-assisted triage and notification software device. CINA-VCF runs on a standard "off the shelf" server/workstation and consists of VCF Image Processing Application, which can be integrated, deployed and used with the CINA Platform (cleared under K200855) or other compatible medical image communications devices. CINA-VCF receives nonenhanced or contrast-enhanced CT scans (which include the chest and/or abdomen) identified by the CINA Platform or other compatible medical image communications device, processes them using algorithmic methods involving execution of multiple computational steps to identify suspected presence of Vertebral Compression Fractures (VCF) findings and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or workstation for worklist prioritization. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a vertebral compressions fracture (VCF). The device uses deep learning models to detect VCF at the T1-L5 level. The models were trained endto-end on a dataset of 886 series collected from multiple centers in the USA and France satisfying the device protocol and representing a large distribution of scanner models from Siemens, Philips, GE and Canon (formerly Toshiba), acquisition protocols, spine presentation and fracture location and severity. Additional models, trained on subsets of this dataset, are used to locate the spine, identify the vertebra bodies and exclude vertebra which have been subjected to vertebroplasty or contains orthopedic material. The Worklist Application displays all incoming suspect cases, each notified case is marked with an icon. In addition, compressed, grayscale, unannotated images that are captioned "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for diagnostic use beyond notification. Presenting the specialist with worklist prioritization facilitates earlier triage by allowing prioritization of images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone. The CINA Platform is an example of medical image communications platform for integrating and deploying the CINA-VCF image processing applications. It provides the necessary requirements for interoperability based on the standardized DICOM protocol and services to communicate with existing systems in the hospital radiology department such as CT modalities or other DICOM nodes (DICOM router or PACS for example). It is responsible for transferring, converting formats, notifying of suspected findings and displaying medical device data such as radiological data. The CINA Platform server includes the Worklist client application which receives notifications from the CINA-VCF Image Processing application.

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.

CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and appropriately trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. Notifications include compressed preview images that 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 it is not intended to be used as a diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

CINA-iPE is a radiological computer aided triage and notification software device. CINA-iPE runs on a standard "off the shelf" server/workstation and consists of an Image Processing Application, which can be integrated, deployed, and used with the CINA Platform (cleared under K200855) or other medical image communications devices. CINA-iPE receives contrast-enhanced CT scans (not dedicated CTPA protocol) including at least a part of the lung identified by the CINA Platform or other medical image communications device, processes them using deep learning algorithms involving the execution of multiple computational steps to identify the suspected presence of an incidental pulmonary embolism and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or worklist prioritization. To identify the suspected presence of pulmonary embolisms, the device uses a deep learning model trained end-to-end on 5.429 cases acquired from US and France, representing a distribution of PE sizes, locations and acquisition protocols, including multiple scanner models from Siemens, Philips, GE and Canon/Toshiba. Additional models are used to locate the aorta and main pulmonary artery, enabling assessment of the contrast timing. The lung's parenchyma is segmented to evaluate both the presence of the lungs in the field of view and to limit the region of interest for detecting the presence of pulmonary embolisms. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of an incidental Pulmonary Embolism (iPE), then active notifications on the flagged series are sent to the Worklist Application. The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the contrast-enhanced CT studies received by CINA-iPE device are displayed in the worklist and those on which the algorithms have detected finding are marked with an icon (i.e., passive notification). In addition, a compressed, grayscale, unannotated image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for diagnostic use beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing prioritization of images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care image interpretation practice alone. The CINA platform is an example of medical image communications platform for integrating and deploying the CINA-iPE image processing application. The medical image communications device (i.e., the technical platform) provides the necessary requirements for interoperability based on the standardized DICOM protocol and services to communicate with existing systems in the hospital radiology department such as CT modalities or other DICOM nodes (DICOM router or PACS for example). It is responsible for transferring, storing, converting formats, notifying of suspected findings and displaying medical device data such as radiological data. The medical image communications server includes the Worklist client application in which notifications from the CINA-iPE Image Processing application are received.

Cina is a radiological computer aided triage and notification software in the analysis of (1) not-enhanced head CT images and (2) CT angiography of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorthage (ICH) and (2) head CT angiography for large vessel occlusion (LVO) of the anterior circulation (distal ICA, MCA-M1 or proximal MCA-M2). Cina uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that 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 it is not intended to be used as a diagnostic device. The results of Cina are intended to be used in conjunction with other patient information and based on professional judgement to assist with triage/prioritization of medical images. Notified clinicians are ultimately reviewing full images per the standard of care.

Cina is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiography studies received by Cina device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD). CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected PE or AD findings. Notifications include compressed preview images that 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 it is not intended to be used as a diagnostic device. The results of CINA CHEST 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 ultimately responsible for reviewing full images per the standard of care.

CINA CHEST is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a pulmonary embolism (PE) or an aortic dissection (AD), then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (PE or AD). All the chest and thoraco-abdominal CT angiography studies received by CINA CHEST device are displayed in the worklist and those on which the algorithms have detected a suspected finding (PE or AD) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiographies of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO). CINA uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that 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 it is not intended to be used as a diagnostic device. The results of CINA 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 ultimately responsible for reviewing full images per the standard of care.

CINA is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.