NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) is an FDA 510(k)-cleared medical device (K013694) manufactured by Nidek, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2002. Regulation: 8.