IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC

IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC is an FDA 510(k)-cleared medical device (K896150) manufactured by Teknar, 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 January 17, 1990. Regulation: 8.