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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 45 Results
ProductCode: KPS Applicant: GE MEDICAL SYSTEMS Decision Date To: 11/30/2021
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argus pet system GE MEDICAL SYSTEMS K923309 09/29/1992
attenuation correction GE MEDICAL SYSTEMS K945652 03/31/1995
cardiac first pass analysis GE MEDICAL SYSTEMS K921777 08/12/1992
ge 4096 plus & ge 2048 GE MEDICAL SYSTEMS K914267 07/16/1992
ge discovery ls system GE MEDICAL SYSTEMS K023988 02/04/2003
ge discovery st system GE MEDICAL SYSTEMS K041220 06/15/2004
ge discovery vct system GE MEDICAL SYSTEMS K050559 03/17/2005
ge positrace/discovery vi pet/ct dual mode oncology scanner GE MEDICAL SYSTEMS K012775 09/18/2001
genie processing and review workstation GE MEDICAL SYSTEMS K964012 01/07/1997
hawkeye 4 option for dual-head variable angle gamma camera GE MEDICAL SYSTEMS K052434 09/27/2005