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Instrumentarium Imaging, Inc.
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DELTA 32 AND DELTA 32 TACT is an FDA 510(k)-cleared medical device (K002472) manufactured by Instrumentarium 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 November 28, 2000. Regulation: 8.