
Alltech Medical Systems America, Inc.
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ECHOSTAR SPICA 1.5T MR SYSTEM is an FDA 510(k)-cleared medical device (K113511) manufactured by Alltech Medical Systems America, 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 May 1, 2012. Regulation: 8.