
Intuitive Imaging Informatics, LLC
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IMAGEQUBE PACS is an FDA 510(k)-cleared medical device (K051037) manufactured by Intuitive Imaging Informatics, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2005. Regulation: 8.