
U-System, Inc.
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MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS is an FDA 510(k)-cleared medical device (K080930) manufactured by U-System, 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 August 6, 2008. Regulation: 8.