ODYSSEY LX, MODEL 211320

ODYSSEY LX, MODEL 211320 is an FDA 510(k)-cleared medical device (K003437) manufactured by Philips Medical Systems (Cleveland), 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 February 1, 2001. Regulation: 8.