
Alltech Medical Systems America, Inc.
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ALLTECH ECHOSTAR 1.5 T MR SYSTEM is an FDA 510(k)-cleared medical device (K082100) 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 August 5, 2008. Regulation: 8.