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Philips Health Care
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CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K120321) manufactured by Philips Health Care. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 16, 2012. Regulation: 8.