iExaminer System with Panoptic Plus

iExaminer System with Panoptic Plus is an FDA 510(k)-cleared medical device (K223381) manufactured by Welch Allyn, 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 March 14, 2023. Regulation: 8.