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The product is intended as an X-Ray source for diagnosis. Operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-Ray examinations being performed. Indication for use – The device is stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of hands of adults and children. Limitations for use – This device is not intended for general radiographic X-Ray examinations other than the indicated use, or for mammographic, bone density, fluoroscopy and angiography applications. The major functions of the Hand Diagnostic Radiography Imaging System is including: - Hand and Wrist radiography - · Hand PA, AP, Oblique, Lateral

The Hand Diagnostic Radiography Imaging System is a stationary digital diagnostic X-ray system designed to use in generating radiographic images of hands or wrist. The Hand Diagnostic Radiography Imaging System consists of a system enclosure (with shielding to protect users from exposure to radiation); an X-ray module consists of the X-ray tube (consists of the X-ray tube, cooling fluid, electronics, and casing), generator, and beam limiter; a CCD camera assists the hand position; and the LCD which provides a imagine to make sure the hand on the right position. The Hand Diagnostic Radiography Imaging System is designed to operate with a Flat Panel Digital X-ray Detector Model Yushan 1417C (K201528), manufactured by InnoCare Inc. The intended operators of the Hand Diagnostic Radiography Imaging System are healthcare professionals familiar with and responsible for the X-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, the Hand Diagnostic Radiography Imaging System adheres to recognized and established industry practices and standards.