
U-Systems, Inc.
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U-SYSTEMS ULTRASOUND SYSTEM USI-2000 is an FDA 510(k)-cleared medical device (K003479) manufactured by U-Systems, 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 January 17, 2001. Regulation: 8.