www.fdanews.com/articles/192795-canons-optical-coherence-tomography-device-grabs-fda-clearance
Canon’s Optical Coherence Tomography Device Grabs FDA Clearance
September 19, 2019
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.