
Usa Instruments, Inc.
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OPEN BREAST COIL (OBC) WITH BIOPSY PLATES is an FDA 510(k)-cleared medical device (K050728) manufactured by Usa Instruments, 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 June 27, 2005. Regulation: 8.