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Chondral Quant is a musculoskeletal post-processing software application that allows assessment of knee cartilage condition based on Magnetic Resonance Imaging (MRI).

The medical device Chondral Quant, software version VA10A, is a musculoskeletal postprocessing application that allows evaluating the status of knee cartilage based on Magnetic Resonance Imaging (MRI). The software is part of the syngo OpenApps framework and can be used from within syngo.via like any other syngo.via workflow. Version VA10A is the initial version of this medical device. Chondral Quant processes a morphological 3D series of the knee joint and performs an automated segmentation of the knee's cartilage. The segmentation may be modified by the user. Chondral Quant will also perform a sub-segmentation of the knee cartilage. Chondral Quant additionally performs volumetry and thickness calculation on the segmented areas. Optionally, it is possible to provide a parametric map as secondary input to Chondral Quant. Commonly, this will be a T2 or T2* map. Chondral Quant will perform a registration of the morphological image and the parametric map and transfer the segmentation to the parametric map. A statistical evaluation of the mapping results for the 21 sub zones will be additionally provided in this case. All output will be provided in the form of a table showing statistical evaluation of the assessment (volume and mean, median and standard deviation of thickness and mapping results for every region). Additionally, Chondral Quant will generate output maps (segmentation map, cartilage thickness map) and 3D models of the segmented cartilage (zone model and thickness model). Finally, a PDF report containing the table values and the 3D models will be generated as output. Alternatively, the application Chondral Quant may also be executed in a "PACS-ready" mode, i.e. fully-automated and without user interaction. The results will be sent to PACS automatically. In this case the series names will be marked with a prefix "AUTO GENERATED" for a clear indication of the automatic mode. The subject device, Chondral Quant with software VA10A, consists of new and modified features that are similar to what is currently offered on the predicate device. The subject device includes the following modifications in comparison to the predicate device: new body region compared to predicate device: - -Automatic segmentation and volumetry of the cartilage - -Thickness calculation

syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.

syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures. syngo.CT Cardiac Planning includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped in the following categories: - . Basic reading: commodity features that are commonly available on CT cardiac postprocessing workstations - Advanced reading: additional features for increased user support during CT cardiac ● postprocessing.

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The apports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods. syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures. The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel. syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments. Scenium display and analysis software sits within the MI Neurology workflow within syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data. Scenium consists of four workflows: - -Database Comparison - -Striatal Analysis - Cortical Analysis - - -Subtraction These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy). The modifications to the syngo.via MI Workflows and Scenium (MI Neurology) software (K173897 and K173597) include the following new features: | Workflow | Workflow-specific Features | |----------------------------------|-----------------------------------------------------------------------------------------------------| | MM Oncology | Interactive Trending | | | Hybrid VRT / MIP ranges | | | Spine and Rib labelling | | MI Neurology (Scenium) | Factory Normals Database for DaTscan™ | | | Export Subtraction and Z-score Images as DICOM | | | Z-score Image Overlay and Threshold Improvements | | MI Reading / SPECT<br>Processing | Renal Enhancements (extrapolation of T1/2) | | | Integrate Image Registration Activity | | MI Cardiology | No updates / changes to third party applications within MI<br>Cardiology or workflow functionality. |