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Mri Interventions, Inc.
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SV BRAIN ARRAY, SIEMENS 3T is an FDA 510(k)-cleared medical device (K111802) manufactured by Mri Interventions, 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 September 7, 2011. Regulation: 8.