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Opal Chiro and 20/20 P-DR are intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.

The Opal Chiro and 20/20 P-DR system represents the straightforward integration of a new digital x-ray receptor panel (cleared in K062376) and our previously cleared (K123644 and K133139) software. The Opal Chiro and 20/20 P-DR are Digital Radiography systems, featuring an integrated flat panel digital detector (FPD). The Opal Chiro and 20/20 P-DR is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion + DR, K123644, wherein we combined our OPAL-RAD software with two new digital panels. The upgrade kits are compatible with modern HF diagnostic X-ray generators like Sedecal and CPI. The 20/20 P-DR has been tested with X-Cel 700/900 series of generators.