
Philips Ultrasound, Inc.
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BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K030455) 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 March 12, 2003. Regulation: 8.