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syngo. CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task. syngo. CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques: - · Multiplanar Reconstruction (MPR) - · Volume Rendering Technique (VRT) - · Perspective surface shaded display (pSSD) - The following evaluation tools are provided with this workflow: - Virtual Flight - · Panoramic View - Polyp Lens - Stool Tagging Stool Subtraction - Polyp Enhanced Viewing (PEV) - Movie syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.

syngo.CT Colonography is a self-contained image analysis software package for evaluating CT volume data sets. The software is designed to support the physician in studying the inside, wall, and outside of the colon. It helps the physician to classify conspicuous regions of tissue with respect to their size, shape, and position. Therefore, it combines tools for - visualization of the data: ● - Panoramic Endoluminal View a) - Stool Tagging b) - Workflow Improvements C) - Virtual Dissection d) - e) Polyp Lens - Stool Subtraction f) - navigation through the CT volume data sets ● - evaluation of potential findings: ● - a) Semi-automatic measurements - reporting of results: - a)

Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners. The device is intended to be used on patients referred for a CT Colonography examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the CTC image data, supporting their evaluation ("second read").

Medicsight ColonCAD API is a medical imaging software tool designed to assist radiologists in the detection of polyps in CT scans of the product is packaged as an Application Programming Interface (API) which allows it to be integrated into existing medical imaging solutions. The ColonCAD API assists the radiologist in detecting colorectal polyps using mathematical image processing techniques. The CAD assists the radiologist by highlighting potential polyps in 2D and 3D image views. The results are displayed in the form of "CAD marks" on or near the potential polyps. The radiologist must assess every CT scan image to search for polyps and review the CAD marked images to determine if the indicated findings are polyps. Patient management decisions should not be made solely on the results of ColonCAD analysis.

Colon CAR 1.2 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images. Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

Colon CAR™ (Computer Assisted Reader) 1.2 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps and other lesions in the colon. The software allows the user to select regions of interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of polyps and measurement of polyp characteristics such as size and volume. The further feature of Colon CAR™ 1.2 as compared to the cleared device is a Polyp Enhanced Viewing Filter (PEV), the results of which are presented in a Joint Reader filter view (enhanced and non-enhanced data viewed simultaneously). The PEV filter identifies intra-colonic filling defects protruding into the colonic lumen, thereby highlighting potential polyp candidates for further interrogation by the reporting radiologist. This filter is fully adjustable and, in deciding the desired characteristics of the objects to be highlighted, the radiologist may specify the degree of object sphericity (or roundness), the height of the protruding object in relation to its base (object 'flatness') as well as select an approximate object diameter range.

syngo Colonography - Software Package with Extended Functionality is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT or MR scanning. The syngo Colonography - Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Polyp Enhanced Viewing), Furthermore workflow improvements, like "segmentation in global view". "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package. This visualization tool allows for volumetric analysis of colonic lesion size over time. helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position. The syngo Colonography - Software Package with Extended Functionality is limited to CT volume data sets.

This pre-market notification covers Siemens syngo Colonography - Software Package with Extended Functionality. It is based on Siemens syngo software platform. syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or lowdose spiral CT or MR scanning. The syngo colonography Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Polyp Enhanced Viewing). Furthermore workflow improvements, like "segmentation in global view", "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package. This visualization tool allows for volumetric analysis of colonic lesion size over time, helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.