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Riverain Medical Group,Llc
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DELTAVIEW MODEL 2.1 is an FDA 510(k)-cleared medical device (K111776) manufactured by Riverain Medical Group,Llc. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 2011. Regulation: 8.