TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K063388) manufactured by Topcon Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2007. Regulation: 8.