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Philips Medical Systems North America, Inc.
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GYROSCAN INTERA (R7.5) is an FDA 510(k)-cleared medical device (K001796) manufactured by Philips Medical Systems North America, 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 September 5, 2000. Regulation: 8.