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The Allura Xper R9 series (within the limits of the used Operating Room table) are intended for use to perform: · Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. · Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: · The Allura Xper R9 series can be used in a hybrid Operating Room. · The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.

The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 interventional fluoroscopic X-ray system include: - Real-time image visualization of patient anatomy during procedures - Imaging techniques and tools to assist interventional procedures - Post processing functions after interventional procedures ● - Storage of reference/control images for patient records ● - Compatibility to images of other modalities via DICOM ● - . Built in radiation safety controls This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper FD series / Allura Xper OR Table series R8.2.1. Configurations are composed of detector type, (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features: - . 12 inch Flat detector (FD12) - 15 inch Flat detector (FD15) ● - 20 inch Flat detector (FD20) . Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.

Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips IntelliSpace Cardiovascular software runs on standard information technology hardware, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components. The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow-up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.

The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. The Spectral enhanced Advanced Vessel Analysis (SAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels. The Spectral enhanced Comprehensive Cardiac Analysis (SCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images. The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.

The Spectral CT Applications package introduces a set of three SW clinical applications: spectral enhanced Comprehensive Cardiac Analysis (sCCA), spectral enhanced Advanced Vessel Analysis (sAVA), and spectral enhanced Tumor Tracking (sTT). Each application provides tools that assist a trained personal in visualization and analysis of anatomical and pathological structures. The sCCA application is targeted to assist the user in analysis and diagnostic of Cardiac Cases, as contrast enhanced and ECG triggered scans. The application input is a cardiac case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the coronary tree and chambers. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the coronary vessel & findings along it. The sAVA application is targeted to assist the user in analysis and diagnostic of CT Angiography cases, as contrast enhanced and whole body CT-angiography scans. The application input is a CT Angiography case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the vessel of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the vessels & findings along it. The sTT application is targeted to assist the user in analysis of tumors, as contrast enhanced, soft tissue oriented, and whole body scans. The application input is a tumor suspected contrast enhanced case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the tumor of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the tumor.

MultiBand SENSE is a software option intended for use on Achieva and Ingenia 1.5T & 3.OT MR Systems. It's indicated for use in magnetic resonance imaging of the brain for BOLD fMRI. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times or increasing coverage or resolution without increasing scan time.

The MultiBand SENSE technique enables simultaneous excitation and acquisition of multiple volumes or slices for the purpose of speeding up acquisition times or increasing coverage or resolution at constant scan time. The simultaneous excitation is done using a multi-band radiofrequency pulse. The unfolding of the simultaneously acquired volumes is done using the SENSE algorithm. The unfolding process (solving the linear equation of the SENSE algorithm) is improved by introducing a linear phase over k-space in the volume direction resulting in a spatial shift of the aliased pixels. The phase shift is applied by additional blip-gradients in the slice direction or switching between different RF pulses, and compensated for in reconstruction by a translation of the coil sensitivity data before the SENSE unfolding. The feature consists of: - Modulated RF pulses exciting 2 or more slices - Blip-gradients to introduce a phase shift for improved unfolding ● - New parameterization of the SENSE calculations ● - Shifting coil sensitivities in reconstruction to correct for linear phase shift. ● MultiBand SENSE is supported on the following systems: - . 3.0T Ingenia - 3.0T Achieva ● - 1.5T Ingenia ● - . 1.5T Achieva The functionality is supported on all available gradient performance levels. Optimized protocols will be provided for the different performance points. MultiBand SENSE is supported on the centralized data acquisition systems of the Achieva systems as well as the digitally networked data acquisition system of the Ingenia systems. The data acquisition system is fully transparent to the MultiBand SENSE pulse sequences and reconstructions. The main functional units in the software are: - Methods (acquisition of MR signals by means of MR pulse sequences) - - Reconstruction (transforming the MR signals to images) - - -Patient Administration (storing of the images in the database and providing access) - Viewing (display of images) - The technical impact of the feature MultiBand SENSE comprises: - -Methods: Introduction of a modulated RF pulse. Apply blipped gradients. Provide new parameterization for SENSE reconstruction. - Reconstruction: Read new parameterization of SENSE calculations. Shift coil sensitivities before SENSE calculations. No off-the-shelf software is used for the feature MultiBand SENSE. The off-the-shelf software used in the basic MR system is cleared. MultiBand SENSE is not designed to be connected to an external network. MultiBand SENSE does not require any change of the hardware platform. The extension introduced by Multiband SENSE, are in methods pulse sequence code, and in reconstruction only for a new parameterization of a cleared SENSE unfolding calculation. Those run on the host computer characteristics : - Manufacturer: HP; Model: Z420; Processor clock: 3.5 GHz; RAM: 64 GB RAM; -Processors: six core with hyper threading - Operating system: Windows 7, 64 bits - The only new element for the operator of the Multiband SENSE feature in this clinical routine workflow is: - Protocol selection: The operator selects an ExamCard with Multiband SENSE protocols - - Planscan phase: Optionally the operator may want to change the predefined Multiband acceleration factor. All other steps are not changed. The generated image types can be viewed, post-processed, printed and archived as any other image type.

The Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, in sterile environments, in a variety of procedures.

The proposed Veradius Unity is a counterbalanced C-arm with a thin flat detector x-ray system. The system consists of two main component parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, user interface for image/patient handling and optionally an integrated workstation)