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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 21 Results
ProductCode: LNH Applicant: GE HEALTHCARE Decision Date To: 08/31/2016
 
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digital expert access with remote scanning GE Healthcare K232346 10/27/2023
ge signa excite mr surgical option GE HEALTHCARE K043262 01/12/2005
signa pioneer GE HEALTHCARE K153003 10/27/2015
signa voyager GE HEALTHCARE K161567 09/01/2016
signapioneer GE HEALTHCARE K160621 03/29/2016
discovery mr750 3.0t, discovery mr450 1.5t, discovery mr750w 3.0t, optima mr450w 1.5t GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) K132376 11/15/2013
optima mr450w GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) K123522 03/13/2013
signa architect GE Healthcare (GE Medical Systems, LLC) K202966 11/13/2020
signa hero GE Healthcare (GE Medical Systems, LLC) K213668 01/20/2022
signa premier GE Healthcare (GE Medical Systems, LLC) K193282 04/10/2020
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