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FDA grants 510(k) clearance to Olympus' EVIS X1 endoscopy system, compatible endoscopes

The FDA granted 510(k) clearance to Olympus Medical for its EVIS X1 endoscopy system and two compatible gastrointestinal endoscopes, according to a manufacturer press release.This clearance encompasses Olympus’ EVIS X1 system, as well as its accompanying GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope for use in the ....

United States , Richard Reynolds , Monica Stonehill , Systems Group For Olympus America Inc , Olympus Medical , Medical Systems Group , Olympus America , Dichromatic Imaging , Color Enhancement Imaging , Adjustment Imaging , Olympu Narrow Band Imaging ,