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The WirelessMired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film /screen or CR systems may be used. The FDR D-EVQ is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that acquires and digitizes x-ray exposures from standard radiographic systems. It is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. The FDR D-EVO FPD system is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The new submission is being submitted for the same FDR D-EVO FPD system to seek the clearance of the pediatric indication for use.

Synapse 3D Base Tools is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Base Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, CR, US, NM, PT, and XA, etc. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Synapse 3D Base Tools provides several levels of tools to the user: - Basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal / oblique / curved Multi-Pianar Reconstructions (MPR), Maximum (MIP), Average (RaySum) and Minimum (MinIP) Intensity Projection, 4D volume viewing, image fusion, image subtraction, surface rendering, sector and rectangular shape MPR image viewing, MPR for dental images, creating and displaying multiple MPR images along an object, time-density distribution, basic image processing, CINE, measurements, annotations, reporting, printing, storing, distribution, and general image management and administration tools, etc. - Tools for regional segmentation of anatomical structures within the image data, path definition through vascular and other tubular structures, and boundary detection. - Image viewing tools for modality specific images, including CT PET fusion and ADC image viewing for MR studies.

The SYNAPSE 3D Base Tools software is medical application software running on Windows Server 2008 installed on commercial general-purpose Windows-compatible computers. SYNAPSE 3D Basic Tools software is connected through DICOM standard to other medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to PACS systems storing data generated by these medical devices. Image data obtained from these devices are used for display, image processing, analysis, etc. SYNAPSE 3D Base Tools cannot be used to interpret Mammography images. SYNAPSE 3D Base Tools can be integrated with Synapse Workstation (cleared by CDRH via K051553 on 07/07/2005) and can be used as a part of a SYNAPSE system. SYNAPSE 3 D Base Tools Version 3.0 expands upon the applications listed in Synapse 3D Basic Tools, #K101662 with the addition of the below new applications. In addition, new and improved algorithms are listed in Section 11.1.4. - Slicer Slicer creates multiple cross-sectional images along an object such as spine with MPR processing using CT or MR data. The user can adjust the location of reference lines manually to obtain desired slices. - Combination Combination can concatenate separated series data acquired for a single body into one single series. - Dental MPR Dental MPR creates a cross-sectional image along the specified line on teeth with MPR, including CPR, processing using head CT data. - ADC Viewer ADC Viewer accepts MR diffused weighted images, calculates ADC (Apparent Diffusion Coefficients) and EADC (Exponential ADC) values for each pixel using the known equations, and displays color mapped ADC and EADC images.

FUJIFILM Unity SpeedSuite X-Ray System is Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The FUJIFILM DR Unity SpeedSuite is a stand-alone X-ray exposure system comprised of a U- arm (manufactured by Sedecal) that incorporates the following: Fuji's image reader equipped with HD Linescan technology, Fuil's CR/DR Console (IIP), and Sedecal's X-ray source and U-Arm system (Verso). Since both are paired, the height and angle can be flexibly changed while maintaining their positional relationship. This system enables you to make an exposure not only at supine or upright position but also at any other desired positions. Images taken by the Unity system are sent to Fuii's IIP (CR/DR Console) to be processed. There is an automatic collimator made by Huestis attached to the tube head. The x-ray tube is manufactured by Toshiba

Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.

Obliquus is an integrated Maximum Intensity Projection (MIP) and Multi-Planar Reformatting (MPR) software package intended to be used with Fuji Synapse Workstation Software Version 3.1.1 and higher. This software is designed to be used by radiologists, clinicians and referring physicians to acquire, process, review, store, print and distribute DICOM compliant image studies utilizing standard PC hardware. Obliquus offers similar user interface and image manipulation functionality as was cleared in Synapse Workstation software version 3.1.0. The Obliquus software enables the user to display MPR visualization of CT or MRI studies in Synapse. Once opened in Synapse, the images can be presented in the following viewers: MPR Viewer: Visualizes a study image of the selected series in the following four types of plane images: (1) Original view is the original CT or MRI study image. (2) Reformatted A view represents visualization of the original view orthogonal to the original study plane (i.e., if original image is axial, then Reformatted A will be of the coronal plane). (3) Reformatted B view represents visualization of the original view orthogonal to the original study plane (i.e., if the original image is axial, then Reformatted B will be of the sagittal plane). (4) Oblique view shows a plane image from any direction specified by the user. Compare Viewer: Compare viewer consists of four windows and up to four series that can be displayed for visual comparison. The Compare viewer functions are as follows: - . Synchronously display images of each series - Make synchronous display setting which includes adjusting slice position and changing . synchro unit - . Switch among 3 orthogonal plane images - Set rendering mode and slab thickness . - Display patient study and image information . - . Toggle with the MPR viewer Stereo Viewer: Presents images for stereopsis, particularly for Magnetic Resonance Angiography (MRA) MIP images. The Stereo viewer's functions include: - . Rotating and displaying plane images horizontally - . Setting image display format - . Setting rendering mode, slab thickness and projection angle interval - . Display patient, study and image information - . Toggle with the MPR viewer Images can be saved either as bitmap files or to the Synapse server.

Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical Images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. The Synapse Workstation may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or mulli-objective frequency image processing for DICOM MG "For Presentation" mammography images.

The Synapse Workstation provides viewing and manipulation of radiological data including images, reports, patient status, and clinical information. The workstation utilizes a folder structure providing easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individue looging In addition to common image manipulation functions such as windowlevel and windowlydth variation, magnification, density value, etc., the Synapse Workstation provides more advanced image processing, including processing of CR and CT images.