OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System is an FDA 510(k)-cleared medical device (K210458) manufactured by ABBOTT MEDICAL. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2021. Regulation: 8.