CS2000 & CS2000 TOMO

CS2000 & CS2000 TOMO is an FDA 510(k)-cleared medical device (K973834) manufactured by Pausch 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 April 29, 1998. Regulation: 8.