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Instrumentarium Corp. Imaging Division
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DELTA 32; DELTA 32 TACT is an FDA 510(k)-cleared medical device (K022275) manufactured by Instrumentarium Corp. Imaging Division. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2002. Regulation: 8.