
Viztek, Inc.
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VIZTEK DR, MODELS: DR1000, DR3000, DR4000 is an FDA 510(k)-cleared medical device (K082604) manufactured by Viztek, 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 November 20, 2008. Regulation: 8.