FDA grants 510(k) clearance to Olympus’ EVIS X1 endoscopy system, compatible endoscopes
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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 lower digestive tract.
“We are thrilled that we will soon be able to bring this new endoscopy system to physicians and their patients in the U.S.,” Richard Reynolds, president of the Medical Systems Group for Olympus America, Inc., said in the release. “As a leading medical technology company, Olympus strives to offer physicians the most advanced technologies for minimally invasive procedures such as GI endoscopy.”
According to the release, the EVIS X1 system includes “three enhancements designed to assist physicians in visualizing GI bleeds and anatomical structures.” These upgrades are enabled by replacing the Xenon bulb from the EVIS Exera III system with five LED bulbs that can produce additional light combinations to white light:
Red Dichromatic Imaging (RDI): Intended for optical-digital observation using red dichromatic narrow band light and green illumination light.
Texture and Color Enhancement Imaging (TXI): Highlights tonal changes, patterns, and image outlines. It is also designed to correct the brightness of dark areas.
Brightness Adjustment Imaging with Maintenance of Contrast (BAI-MAC): Maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image.
The EVIS X1 system also features Olympus’ Narrow Band Imaging (NBI) technology, intended to enhance observation of mucosal tissue by filtering white light into specific wavelengths that are absorbed by hemoglobin and only penetrate the surface of human tissue. Using this feature, capillaries on the mucosal surface will appear brown and veins in the submucosa will appear cyan on the monitor.
Olympus noted that “NBI, RDI, TXI and BAI-MAC technologies are not intended to replace histopathological sampling as a means of diagnosis technologies,” but are only intended to supplement endoscopic examination tools.
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