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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 15 Results
ProductCode: OWB Applicant: GE MEDICAL SYSTEMS Decision Date To: 05/30/2023
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vision 2, evarvision, trackvision 2, heartvision 2 GE Medical Systems SCS K223152 11/22/2022
stereo 3d option for vision applications GE MEDICAL SYSTEMS, SCS K152352 01/20/2016
discovery igs 740 GE MEDICAL SYSTEMS SCS K133278 04/24/2014
ge discovery igs angiographic,fluoroscopic x-ray system GE MEDICAL SYSTEMS SCS K113403 02/14/2012
innova 2121iq, innova 3131iq, innova 4100, innova 4100iq, innova 3100, innova 3100iq, innova 2100iq with innova ivus opt GE MEDICAL SYSTEMS, LLC K061163 06/07/2006
digital fluoroscopic imaging systems - innova 3131 & innova 2121 GE MEDICAL SYSTEMS, LLC K060259 02/22/2006
innova 2100 GE MEDICAL SYSTEMS, LLC K050489 03/11/2005
innova 4100, innova 3100 GE MEDICAL SYSTEMS, INC. K042053 08/26/2004
digital fluoroscopic imaging system, model innova 4100 with tilt table option GE MEDICAL SYSTEMS, INC. K033244 10/16/2003
innova 3100 GE MEDICAL SYSTEMS K031637 08/22/2003