PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS

PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS is an FDA 510(k)-cleared medical device (K082243) manufactured by General Medical Merate S.P.A. 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 6, 2008. Regulation: 8.