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Philips Healthcare Informatics, Inc.
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INTELLISPACE PACS 4.X is an FDA 510(k)-cleared medical device (K111804) manufactured by Philips Healthcare Informatics, 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 July 27, 2011. Regulation: 8.