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Usa Instruments, Inc.
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HI-RES 9000 PHASED ARRAY CAROTID COIL is an FDA 510(k)-cleared medical device (K001210) 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 8, 2000. Regulation: 8.