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FUJIFILM Synapse Workstation Software is intended for installation on an off-theshelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The FUJIFILM 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 to process DICOM MG "For Processing" images and also 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 for mammography.

The FUJIFILM Synapse Workstation Software Version 3.3.0 is PACS workstation software and an integral component of the Fuji Synapse PACS. Synapse Workstation Software Version 3.3.0, provides processing, viewing and manipulation of radiological data including images, reports, patient status, and clinical information. The workstation utilizes a folder structure oroviding 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 individual requirements. The common and basic image manipulation functions such as window/level and window/width variation, magnification, density value, etc., are available for mammography as well as nonmammography images. In addition to common image manipulation functions the Synapse Workstation Software Version 3.3.0 provides image processing sub-systems for processing images from various modality types such as Fuji CR, Fuji MG, CT, along with general image processing for any SOP class image.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the FUJIFILM Synapse Workstation Software Version 3.3.0, focusing on its substantial equivalence to predicate devices and its indications for use.

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