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syngo.via WebViewer is a software-only device indicated for reviewing medical images from syngo via. It supports interpretation and evaluations within healtheare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments (supported Image types: CT, MR, CR, DR, DX, PET). It is not intended for storage or distribution of medical images. syngo.via WebViewer is an option for the syngo.via system and cannot be run without it. It is client server architecture and the client is intended to run on web clients which are connected to the healtheare institution IT infrastructure where the customer will insure HIPAA compliance. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the display of digital mammography images for diagnosis.

The syngo.via WebViewer is a software-based Picture Archiving and Communications System (PACS) used with the syngo.via system. The syngo.via WebViewer provides secure access to rendered medical image data and basic image manipulation through web browsers and mobile devices within the reach of the hospital network. It extends the syngo.via WebViewer software application previous cleared under K111079. New image types supported are PET and X-Ray images. It also provides functionality for displaying images via a mobile application on an iPad.

syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. The predicate device, syngo.via allows for the use of a variety of advanced applications (clinical applications) These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.

The syngo.CT Dynamic Angio software package has been designed to evaluate CT data which has been continuously acquired with computed tomography (CT) imaging systems. Contrast enhanced CT images are used to visualize the flow of contrast from the arteries to the veins. syngo.CT Dynamic Angio can be used to assist the physician in the diagnosis of blood vessels and it supports in the evaluation of regions of interest, the visual inspection of time attenuation curves, and the creation of specific CT volumes, for example, arterial or venous phase. It will aid in the inspection of diseases which affect the vessel system, for example, vessel stenosis, collateral or late filling of vessels, vascular malformations, control of stent graft extravasation, or in the evaluation of tumor vascularization.

syngo.CT Dynamic Angio is a software, which was developed to visualize dynamic CT datasets in a three and four dimensional view. Possible input data are Siemens CT Dynamic Sequence, Dynamic Multiscan, Adaptive 4D Spiral and Heart Perfusion Scanning datasets. syngo.CT Dynamic Angio supports the overlay free visualization of the vessel enhancement with the help of motion correction and bone segmentation. The software can be used to run a movie of a time series or to create CT phase volumes (e.g. arterial phase or venous phase) by combining multiple neighboring time points from the dynamic CT data. It also supports the evaluation of regions of interest and the visual inspection of time attenuation curves. syngo.CT Dynamic Angiois a post-processing software package which provides a combination of functionality similar to functionality provided by one or more of the predicate devices as listed above. It uses the same data for evaluation as the predicate devices and provides results in the same format as the predicate devices All result volumes created by CT Dynamic Angio are stored in separate series and consist of a set of standard DICOM single frame CT images. All finding snapshot images are stored in a different series as DICOM secondary captures. As basis for data viewing, syngo.CT Dynamic Angio uses basic reader and image display functionality as provided by syngo.via. Different visualization filters like multiplanar reformatting (MPR, MPR Thick), maximum intensity projection (MIP, MIP Thin) and volume rendering techniques (VRT, VRT Thin) can be applied. Windowing of the visualized data cao be done by mouse interaction and with predefined CT window presets. Zooming and panning of the CT volumes is supported. In addition to basic viewing capabilities, syngo.CT Dynamic Angio provides tools for visualization, analysis and reporting of vascular conditions. Standard syngo.via analysis tools are Distance Line, Pixel Lens, Marker, Arrow and ROI (Region of Interest).

syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via. The system cannot be used as stand-alone device. It is intended to be an option for syngo.via system only. syngo.via WebViewer is not intended for storage or distribution of medical images from one medical device to another. syngo.via WebViewer is a client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer has to ensure HIPPA compliance. syngo.via WebViewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

This premarket notification covers Siemens ' PACS syngo.via WebViewer. syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via. The system cannot be used as stand-alone device. It is intended to be an option for syngo via system only. syngo. via Web Viewer is not intended for storage or distribution of medical images from one medical device to another. syngo.via WebViewer is a client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer has to ensure HIPPA compliance. syngo. via Web Viewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning.

syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.

syngo plaza is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. syngo.plaza will be installed by Siemens service engineers. The backend communication and storage solution is based in Windows 2008 operating systems as described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519) The syngo plaza will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be I any spond individual service contract and fulfilled by special trained service technicians. This is also applicable for the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The herewith described syngo plaza VA20A supports DICOM formatted images and This which is also described for the predicate devices syngo.plaza VA10A (093612), syngo.x (K092519) and syngo Imaging (K071114).

Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

Syngo.CT Coronary is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

syngo plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting. In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

syngo. plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo. plaza optionally uses a variety of advanced post processing applications. syngo.plaza is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo.plaza will be installed by Siemens service engineers. Defined Hardware requirements are to be met. The herewith described syngo.plaza supports DICOM formatted images and objects.

The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not Intended to be used as a replacement for screening mammography.

This premarket notification covers the Siemens ABVS Workplace, an offline image viewing workstation. The ABVS workplace consists of common IT hardware and preinstalled software to ensure that defined hardware requirements are met. The workplace is based on Windows XP.

syngo.x is a software solution intended to be used for viewing, manipulation, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo.x based software options. syngo.x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

This premarket notification covers Siemens enhanced PACS system syngo.x. syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo x based software options. syngo x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. syngo.x also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.x integrates Radiology Information Systems (RIS) to enable customer specific workflows. syngo.x allows to use a variety of advanced applications (clinical applications) designed for syngo.x just as the predicate device syngo MultiModality Workplace (K072728, cleared on April 22, 2007). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo x medical device. syngo.x has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and postprocessing algorithms compared to the above mentioned predicate devices. syngo.x is based on Windows. Due to special customer requirements and the clinical focus syngo.x can be configured in the same way as the syngo MultiModality Workplace with different combinations of syngo.x- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. syngo.x is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. This hardware has to fulfil the · defined requirements. The Software will be installed by Siemens service engineers only. The herewith described syngo.x supports DICOM formatted images and objects. The syngo.x will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians.

The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves. A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

syngo® Volume Perfusion-CT Body software package with extended functionality is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ....). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.