XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is an FDA 510(k)-cleared medical device (K193319) manufactured by Vasoptic Medical, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2020. Regulation: 8.