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MAR 2 12014 Sedecal Special 510 k Summary 510 k Number K133782 1. Submitter SEDECAL SA C/ Pelaya 9 - 13 Pol. Ind. 5. 9 million pixels 55C or Scintillator Tube Mount GOB Gd2O2S Tb Column Suspension 9. 5 Megapixels 501C CsI Csl TI Ceiling Suspension 7. The modifications are shown in the comparison table below. /yc Comparison Table Modified Device Sedecal NOVA FA DR Predicate K090279 Sedecal Millennium Plus Digital Diagnostic X-Ray Systems. Discussion of the nonclinical tests in the premarket...
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