
Opko Instrumentation, Inc.
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OTI-SCAN 3000 is an FDA 510(k)-cleared medical device (K092837) manufactured by Opko Instrumentation, 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 December 22, 2009. Regulation: 8.