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The Series 7600 Mobile Digital C-arm is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. The document describes the device, its intended use, and substantial equivalence to other marketed devices. It also lists the standards the device complies with. There is no performance data, clinical study information, or details about ground truth establishment.

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