
Mri Devices Corp.
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HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA is an FDA 510(k)-cleared medical device (K001713) 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 June 13, 2000. Regulation: 8.