RTVue XR OCT Avanti with AngioVue Software

RTVue XR OCT Avanti with AngioVue Software is an FDA 510(k)-cleared medical device (K153080) manufactured by Optovue, 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 February 10, 2016. Regulation: 8.