B-400 CEILING MOUNTED POSSITIONER, MODEL B-400

B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 is an FDA 510(k)-cleared medical device (K990055) manufactured by Omega Medical Imaging, 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, 1999. Regulation: 8.