DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K001336) manufactured by Analogic Corp.. 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 1, 2000. Regulation: 8.