ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS is an FDA 510(k)-cleared medical device (K013088) manufactured by Echotech 3D Imaging Systems, 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 April 3, 2002. Regulation: 8.