ECHOTECH 3D FREESCAN

ECHOTECH 3D FREESCAN is an FDA 510(k)-cleared medical device (K980308) manufactured by Echotech 3D Imaging Systems GmbH. 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 5, 1998. Regulation: 8.