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The DGTX CAL is an in vitro diagnostic product for the calibration of digitoxin on the Dimension Vista® System.

The DGTX CAL is a liquid bovine serum based product containing digitoxin.

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

The Koordinat Table family is a modification to an existing floor mounted X-ray table for angiographic examinations and interventions, and surgery. The modified Koordinat table is based on knowledge and experience gained with the predecessor model, the Koordinat M Table. The Koordinat M was described in the 510(k) Submitted on 4/30/95 with the number K951176.

The AX Workstation DR-Viewer Software Option offers the ability to visualize composite images of selected anatomy (i.e. spine, legs, colon). The images produced by the package, as well as the measurement tools of DR-Viewer, are intended to assist the physician in diagnosis and treatment of musculoskeletal disorders and conditions of the gastrointestinal tract.

The AX Workstation DR-Viewer Software Option uses a series of images of the anatomy (i.e. spine, legs, colon) generated with a radiographic, fluoroscopic, or angiographic x-ray system, and reconstructs the images into a single composite image format. After reconstruction of the image, the software provides the user with various measurement tools and post-processing functions.

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the High End Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes.

The SOMATOM Plus 4 with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)

The SOMATOM Plus 4 with Sliding Gantry Option is a whole body X-ray computed tomography scanner that features a continuously rotating tube-detector system and functions according to the fan beam principle. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. This is achieved by mounting the gantry on a dedicated rail system and by having a scan control system that moves the gantry relative to the table instead of moving the table relative to the gantry.

The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.

The BOLD MRI Package is an postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems

The Perfusion Package for MAGNETOM Vision and Symphony MR Systems is a software package which allows the display of temporal variations in dynamic MR Datasets, showing changes in contrast over time. Its purpose is to provide either time intensity curves or the creation of parametric images for parameters like time to peak that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis. One clinical application where this could be useful is the diagnosis of lesions by temporal analysis of tumor enhancement.

The Perfusion Package is a post processing option for the MAGNETOM VISION and SYMPHONY MR system.

Perfusion CT is an application software package that permits cerebral perfusion imaging based on dynamic CT images continuously acquired after the injection of contrast. The package allows visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion related parameters (i.e. relative cerebral blood flow, relative cerebral blood volume, time to peak). By generating images of cerebral blood flow (CBF), cerebral blood volume (CBV), and local bolus timing (i.e. time to peak) from one set of dynamic CT images, Perfusion CT aids the physician in the assessment of the type and extent of cerebral perfusion disturbances. The software package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.

Perfusion CT 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 SOMATOM Plus 4, SOMATOM AR.STAR, SOMATOM Classic). 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. Perfusion CT calculates the parameters related to brain perfusion and cerebral blood flow (CBF) using a simple linear relationship between the detected change of signal and the actual concentration of contrast media.