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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 84 Results
ProductCode: LNH Applicant: GE MEDICAL SYSTEMS Decision Date To: 10/22/2016
 
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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
signa creator, signa explorer GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) K143251 02/04/2015
1.5t infinity twinspeed mr system GE MEDICAL SYSTEMS K012200 08/03/2001
advantage windows tissue volume option GE MEDICAL SYSTEMS K963345 10/18/1996
advantage workstation pasting 1.1 GE MEDICAL SYSTEMS K031396 05/13/2003
fiesta imaging option GE MEDICAL SYSTEMS K002997 04/11/2001
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