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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 44 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
cardiq flow GE Medical Systems SCS K192277 02/14/2020
code ac: attenuation correction system for dual-head variable-angle gamma camera with coincidence option (code) GE MEDICAL SYSTEMS F.I. HAIFA K994167 03/07/2000
cortex id suite GE MEDICAL SYSTEMS, LLC K141074 09/18/2014
discovery iq GE MEDICAL SYSTEMS, LLC K141477 09/18/2014
discovery mi GE Medical Systems, L.L.C. K161574 08/11/2016
discovery mi gen2 GE Medical Systems, LLC. K211846 08/20/2021
discovery model nm/ct 670 GE MEDICAL SYSTEMS F.I. HAIFA K093514 12/10/2009
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