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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 26 Results
ProductCode: JAK Applicant: GE MEDICAL SYSTEMS, LLC Decision Date To: 09/25/2016
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ge brightspeed delight ct scanner system GE MEDICAL SYSTEMS, LLC K082816 10/08/2008
ge lightspeed 7.2 ct scanner system GE MEDICAL SYSTEMS, LLC K082761 10/08/2008
ge lightspeed xtra ct scanner system GE MEDICAL SYSTEMS, LLC K060052 04/19/2006
ge xtreme injector option GE MEDICAL SYSTEMS, LLC K082960 10/17/2008
innova ct option for digital fluoroscopic imaging systems innova models 4100, 4100iq, 3100, 3100iq & 2100iq GE MEDICAL SYSTEMS, LLC K052157 08/25/2005
lightspeed 6.0 ct scanner system GE MEDICAL SYSTEMS, LLC K033502 11/20/2003
lightspeed 7.0 ct scanner system GE MEDICAL SYSTEMS, LLC K040372 03/01/2004
lightspeed 7.1 ct scanner system GE MEDICAL SYSTEMS, LLC K061817 07/12/2006
low dose ct lung cancer screening option for qualified ge systems GE Medical Systems, LLC K151372 08/14/2015
maxfov 2 GE Medical Systems, LLC. K203617 03/02/2021
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