
Mri Devices Corp.
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MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL is an FDA 510(k)-cleared medical device (K040348) manufactured by Mri Devices 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 March 8, 2004. Regulation: 8.