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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K103330
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GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 Syst... 2 02/09/2022 GE Healthcare, LLC
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic r... 2 08/02/2017 GE Medical Systems, LLC
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa P... 2 05/01/2013 GE Healthcare, LLC
10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) ... 2 02/24/2011 GE Healthcare, LLC
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