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Medical Devices / Submissions and Approvals

Canon’s Optical Coherence Tomography Device Grabs FDA Clearance

Sept. 20, 2019
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The FDA has granted 510(k) clearance for Canon’s Xephilio OCT-A1, an optical coherence tomography device that is used to create high resolution images of a patient’s retina.

The non-invasive device is indicated for in-vivo imaging and measurement of the retain, optical disc and retinal nerve fiber layer, and can help clinicians diagnose and manage retinal diseases.

The Xephilio OCT-A1 works with a computer, LCD monitor and Canon’s RX Capture software and is designed for easy use, preserving the scan position and protocol for each patient to eliminate the need for manual adjustment.

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