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Cardiovascular Imaging Solutions , Ltd.
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CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS is an FDA 510(k)-cleared medical device (K073194) manufactured by Cardiovascular Imaging Solutions , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2008. Regulation: 8.