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The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems 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. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed includes minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" (VE21) is medical diagnostic software for realtime 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 a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens "syngo Application Software" (VE21) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS pheno (VE2) system is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE2) system is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, available for the support of dedicated clinical workflows. The ARTIS pheno (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and radiographic/ fluoroscopic procedures. 1) The following components are configured to create the ARTIS pheno VE2 system: Floor stand with C-arm, X-ray tube assembly and FD 2) Patient table 3) Display ceiling suspension with displays 4) Footswitch for releasing radiation 5) Control console for controlling the stand, patient table, collimator and imaging system. Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts. Post processing can be done in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS pheno (VE2) System is capable of 2D and 3D imaging. Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS pheno (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

The Siemens Biograph Horizon PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and re staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. This CT system can be used for low dose lung cancer screening in high risk populations.* * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Biograph Horizon PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software. Biograph Horizon software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The software for the Biograph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include, corrections to software anomalies and addition of new software features, including: - OncoFreeze - OncoFreeze AI (Data Driven Gating) - CardioFreeze - FlowMotion Multi-Parametric PET AI ● - PET FAST Planning (FlowMotion Al) - FAST PET Workflow - QualityGuard - . Updates to HD FoV - Updates to PET DICOM dose Report - Whole Body Scatter Correction Additionally, minor modifications have been made to the computers due to obsolescence issues and to the controllers of the PHS for cost improvement. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens 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 image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diaming and treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

The "syngo Application Software" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time 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 a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens "syngo Application Software" (VE2) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission. The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. The "syngo Application Software" (VE2) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remains the same.

Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Your MAGNETOM MR system may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.

The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).

Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. Artis can also support the acquisition of position triggered imaging for spatial data synthesis. The Artis systems include also the software option DynaCT with following IFU: DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The Artis Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software. Siemens currently markets the Artis zee / zeego (K141574) and the Artis Q / Q.zen (K123529). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen (K123529). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality. Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems. The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions. This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 (K141574) and Artis Q / Q.zen SW Version VD10 (K123529). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image-guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application 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, the syngo Application Software can be deployed on systems 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 image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems. The syneo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The syngo Application Software 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 a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens syngo Application Software is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the syngo Application Software cleared in K162541. Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance for new software features to the syngo Application Software. Proposed Device Modifications: - 1. Enhanced syngo Embolization Guidance - 2. Proposed new product claims associated with device. The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens Angiography Systems. The combination of syngo Application Software and the Siemens released PC Hardware will be marketed as components of the syngo X Workplace. The syngo Application Software is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System.