B-350 CEILING MOUNTED C-POSITIONER

B-350 CEILING MOUNTED C-POSITIONER is an FDA 510(k)-cleared medical device (K970947) 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 May 13, 1997. Regulation: 8.