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Philips Ultrasound, Inc.
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PHILIPS IU22 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K042540) manufactured by Philips Ultrasound, 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 October 3, 2004. Regulation: 8.