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AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR predefined structures using deep-leaming-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT. The output of AI-Rad Companion Organs RT are intended to be used by trained medical professionals. The software is not intended to automatically detect or contour lesions.

AI-Rad Companion Organs RT provides automatic segmentation of pre-defined structures such as Organs-at-risk (OAR) from CT or MR medical series, prior to dosimetry planning in radiation therapy. AI-Rad Companion Organs RT is not intended to be used as a standalone diagnostic device and is not a clinical decision-making software. CT or MR series of images serve as input for AI-Rad Companion Organs RT and are acquired as part of a typical scanner acquisition. Once processed by the AI algorithms, generated contours in DICOM-RTSTRUCT format are reviewed in a confirmation window, allowing clinical user to confirm or reject the contours before sending to the target system. Optionally, the user may select to directly transfer the contours to a configurable DICOM node (e.g., the TPS, which is the standard location for the planning of radiation therapy). The output of AI-Rad Companion Organs RT must be reviewed and, where necessary, edited with appropriate software before accepting generated contours as input to treatment planning steps. The output of AI-Rad Companion Organs RT is intended to be used by qualified medical professionals. The qualified medical professional can perform a complementary manual editing of the contours or add any new contours in the TPS (or any other interactive contouring application supporting DICOM-RT objects) as part of the routine clinical workflow.

AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images.

AI-Rad Companion Brain MR VA50 is an enhancement to the predicate, AI-Rad Companion Brain MR VA40 (K213706). Just as in the predicate, the brain morphometry feature of AI-Rad Companion Brain MR addresses the automatic quantification and visual assessment of the volumetric properties of various brain structures based on T1 MPRAGE datasets. From a predefined list of brain structures (e.g. Hippocampus, Caudate, Left Frontal Gray Matter, etc.) volumetric properties are calculated as absolute and normalized volumes with respect to the total intracranial volume. The normalized values are compared against age-matched mean and standard deviations obtained from a population of healthy reference subjects. The deviation from this reference population can be visualized as 3D overlay map or out-of-range flag next to the quantitative values. Additionally, identical to the predicate, the white matter hyperintensities feature addresses the automatic quantification and visual assessment of white matter hyperintensities on the basis of T1 MPRAGE and T2 weighted FLAIR datasets. The detected WMH can be visualized as a 3D overlay map and the quantification in count and volume as per 4 brain regions in the report.

AI-Rad Companion (Cardiovascular) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: - Segmentation and volume measurement of the heart - Quantification of the total calcium volume in the coronary arteries - Segmentation of the aorta - Measurement of maximum diameters of the aorta at typical landmarks - Threshold-based highlighting of enlarged diameters The software has been validated for non-cardiac chest CT data with filtered backprojection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input.

AI-Rad Companion (Cardiovascular) SW version VA20 is an enhancement to the previously cleared device AI-Rad Companion (Cardiovascular) K183268 that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of cardiovascular diseases. As an update to the previously cleared device, the following modifications have been made: Segmentation of Aorta – Performance Improvement Although the structure of the underlying neural network has not changed in the subject device of this submission, the performance was enhanced over the previously cleared device by adding training data (re-use of existing annotations + 267 additional annotations). Aorta diameter measurements - Maximum Diameter Ascending, Descending Aorta In the previously cleared device diameter measurements of the aorta were performed at nine predefined locations according to the AHA guidelines. As an enhancement to the previously cleared device and subject of this submission are aorta diameter measurements at the locations of the maximum diameter of the ascending and the descending aorta. Visualization of aorta's VRT and as cross-sectional MPRs - Maximum Diameter Ascending, Descending Aorta In the previously cleared device visualization VRT and cross-sectional MPRs were provided at nine predefined locations according to the AHA guidelines. As an enhancement to the previously cleared device, such visualization of the maximum diameter of the ascending and descending aorta were added to the subject of this submission. Categorization of diameter measurements - Maximum Diameter Ascending, Descending Aorta In the previously cleared device categorization of diameter measurements was performed at locations according to the AHA guidelines. With the subject of this submission, the categorization of diameter measurements was extended to locations of the maximum diameter of the ascending and descending aorta. Individual Confirmation of Aorta Findings For the measurements of the aorta, only all the measurements could be accepted or declined in the predicate device. Within the scope of this submission the concept of individual accept, decline-possibility was introduced to all aorta measurements. Structured DICOM Report (DICOM TID 1500) In the predicate device, the system would produce results in form of quantitative, structured and textual reports and would generate DICOM Secondary Capture images which would be forwarded to PACS reading and reporting systems. Within the scope of this submission, the system supports an alternative, digital output format for the same results. For this purpose, a DICOM Structured Report is generated which is both human and machine readable and, therefore, will support, e.g., a transfer of the results into the clinical report more efficiently. The DICOM Structured Report is compliant to the TID1500 format for applicable content. Cloud and Edge Deployment Another enhancement provided within this submission is the existing cloud deployment in an on-premise deployment known as an edge deployment. The system remains hosted in the teamplay digital health platform and remains driven by the AI-Rad Companion Engine; however, with the edge deployment the processing of clinical data and the generation of results is performed within the customer environment. This system remains fully connected to the cloud for monitoring and maintenance of the system from a remote setup. At the time of this submission this feature has been cleared in submission K213706 (AI-Rad Companion Brain MR VA40) and is unchanged within this subject device.