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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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1.5t infinity twinspeed mr system GE MEDICAL SYSTEMS K012200 08/03/2001
1.5t optima mr430s GE MEDICAL SYSTEMS, LLC K103238 02/11/2011
1.5t signa hdxt 3.0t signa hdxt signa vibrant GE MEDICAL SYSTEMS, LLC K121676 09/20/2012
3.0t signa vh/i magnetic resonance system GE MEDICAL SYSTEMS, INC. K990550 05/11/1999
3d asl GE MEDICAL SYSTEMS, LLC K092925 01/06/2010
advantage windows tissue volume option GE MEDICAL SYSTEMS K963345 10/18/1996
advantage windows volume rendering option GE MEDICAL SYSTEMS, INC. K972399 09/23/1997
advantage workstation pasting 1.1 GE MEDICAL SYSTEMS K031396 05/13/2003
air recon dl GE Medical Systems,LLC (GE Healthcare) K213717 06/08/2022
brainstat software option for ge signa mr scanner GE MEDICAL SYSTEMS, LLC K073167 01/04/2008
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