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Diagnostic Ultrasound Corp.
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BLADDERSCAN BVI 6100 is an FDA 510(k)-cleared medical device (K022153) manufactured by Diagnostic Ultrasound Corp.. 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 14, 2002. Regulation: 8.