RetCam 3 ; RetCam Shuttle ; RetCam Portable

RetCam 3 ; RetCam Shuttle ; RetCam Portable is an FDA 510(k)-cleared medical device (K182263) manufactured by Natus Medical Incorporated. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 2018. Regulation: 8.