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Ivu Imaging Corporation
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SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) is an FDA 510(k)-cleared medical device (K080555) manufactured by Ivu Imaging Corporation. 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 2, 2008. Regulation: 8.