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Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is intended to visualize blood vessel structures by detecting the movement of the contrast bolus during angiography examination and to give the medical experts the option to reduce x-ray dose. The effectively achievable radiation reduction depends on the characteristics of the different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally appled acquisition protocols. The software is intended to be used in addition to, or as a replacement for current DSA imaging. KMT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting. It can be configured within a network to send and receive DICOM data. Furthermore, KMIT v4.0 can be deployed on several kinds of angiography systems. It provides solutions in the operating room for imageguided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be also combined with fluoroscopic or radiographic systems.

The Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, optimization, communication, reporting, and storage of medical images and data on exchange media. It provides imageguided solutions in the operating room, for image-guided surgery, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. KMIT v4.0 is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems. The algorithm behind the Digital Variance Angiography (DVA) image calculation is the same in KMIT v2.2 (Kinepict Health Ltd. under K190993) and v4.0 (see Device Description / Calculation of DVA section). The postprocessing functions like contrast and brightness settings, choosing mask image, pixel shift applications, and anonymizing options are the same in the two software. Image storing and image sending functions are using the same DICOM technic and ports as Kinepict Medical Imaging Tool v2.2. In v4.0 automatic upload to PACS and automatic opening of screen size view is implemented. These differences do not have any effect on safety and efficiency. In summary, the KMIT v4.0 software does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

Kinepict Medical Imaging Tool version v2.2 is intended to visualize blood vessel structures by detecting the movement of the contrast medium bolus in standard-of-care angiography examination. This software is intended to be used in addition to, or as replacement for current DSA imaging. Kinepict Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, Kinepict Software can be deployed on systems of several angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. Kinepict Software can also be combined with fluoroscopy systems or Radiographic systems.

The Kinepict Medical Imaging Tool is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with Syngo Application Software VD11 (Siemens Medical Solutions USA Inc. under K153346) or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Kinepict Medical Imaging Tool is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, platform