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Advanced Imaging Research Dba Sree Medical Systems
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INFANT ARRAY is an FDA 510(k)-cleared medical device (K113365) manufactured by Advanced Imaging Research Dba Sree Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2012. Regulation: 8.