IMIX INSIGHT X-RAY SYSTEMS

IMIX INSIGHT X-RAY SYSTEMS is an FDA 510(k)-cleared medical device (K073114) manufactured by Imix Adr Finland OY. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2008. Regulation: 8.