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Synapse 3D Liver and Kidney Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Liver and Kidney Analysis accepts DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse 3D Base Tools, Synapse 3D Liver and Kidney Analysis uses contrast enhanced images of the body and provides custom workflows and UI, and reporting functions for liver and kidney analysis including, liver and peripheral organ segmentation, and tumor segmentation of intrahepatic and peripheral vessels as well as the approximation of vascular territories is provided using contrast enhanced computed tomographic images.

Synapse 3D Liver and Kidney Analysis (V4.0) (this submission) is updated software of previously-cleared Synapse 3D Liver Analysis (cleared by CDRH via K110186 on 04/07, 2011) with expanded IFU and revised device name. The new feature in Synapse 3D Liver and Kidney Analysis (V4.0) are Kidney Analysis (CT) function and Liver Analysis (MR). Synapse 3D Liver and Kidney Analysis is medical application software running on Windows standalone and server/client configuration installed on a commercial general-purpose Windowscompatible computer. It offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans. Synapse 3D Liver and Kidney Analysis is an optional software module that works with Synapse 3D Base Tools (cleared by CDRH via K120361 on 04/06/2012) which is connected through DICOM standard to medical devices such as CT, MR. CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medial devices, and it retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated information of the image data is registered in the database and is used for display, image processing, analysis, etc. Synapse 3D Liver and Kidney Analysis can handle images of CT and MR. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer. The liver and kidney analysis tools both segment the organs, peripheral organs and vessels using similar body part recognition algorithms already available in the FDA-cleared Base Tools (K120361) and the Liver Analysis (CT) (K110186). The technical characteristics and principles of operations are described in details in the Device Description section, which includes the Liver Analysis (CT and MR) and Kidney Analysis (CT). Based on the cleared functions, Synapse 3D Liver and Kidney Analysis enhances the custom workflows and UI to improve the usability. Synapse 3D Liver and Kidney Analysis with Synapse 3D Base Tools can be integrated with Fujifilm's Synapse PACS, and can be used as a part of a Synapse system. Synapse 3D Liver and Kidney Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes. In summary, this 510(k) submission introduces the Synapse 3D Liver and Kidney Analysis with the added capability of performing Liver (MR) and Kidney (CT) Analysis.