
Sonocine, Inc.
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SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 is an FDA 510(k)-cleared medical device (K082543) manufactured by Sonocine, 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 13, 2008. Regulation: 8.