TERATECH, MODEL 2000 IMAGING IMAGING

TERATECH, MODEL 2000 IMAGING IMAGING is an FDA 510(k)-cleared medical device (K992505) manufactured by Teratech 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 November 9, 1999. Regulation: 8.