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Ziehm Imaging, Inc.
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ZIEHM VISION 2 is an FDA 510(k)-cleared medical device (K073346) manufactured by Ziehm Imaging, 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 March 20, 2008. Regulation: 8.