FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is an FDA 510(k)-cleared medical device (K200022) manufactured by Livermoretech, 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 April 2, 2020. Regulation: 8.