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Xephilio OCT-A1 receives 510(k) clearance

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The FDA has granted 510(k) clearance to Canon U.S.A.’s Xephilio OCT-A1 OCT device, according to a press release.

Together with the RX Capture software, computer and LCD monitor, the Xephilio OCT-A1 system is indicated for in vivo imaging and measurement of the retina, retinal nerve fiber layer and optic disc, and is used to diagnose and manage retinal diseases, the release said. It has a scanning speed of 70,000 A-scans per second with optical depth resolution of approximately 3 µm.

“Designed to meet the needs of customers, the Xephilio OCT-A1 system is a user-friendly solution designed to help health care professionals capture high-resolution images and scans with ease and efficiency,” Tsuneo Imai, vice president and general manager, Healthcare Solutions, Business Information Communications Group, Canon U.S.A., said in the release.