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The Models 2200DR and 1600DR Digital Stationary Radiographic Systems are 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. Not for mammography.

This device represents a new combination of an already cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature.