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Siemens Medical Systems USA
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SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE is an FDA 510(k)-cleared medical device (K111861) manufactured by Siemens Medical Systems USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2012. Regulation: 8.