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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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vtransact: attenuation correction system for dual-head variable angle gamma camera GE MEDICAL SYSTEMS F.I. HAIFA K980959 06/04/1998
vpc-94 ultra high energy collimaters model numbers 480-685-9402 GE MEDICAL SYSTEMS F.I. HAIFA K981352 07/13/1998
ventri 1.1 GE MEDICAL SYSTEMS F.I. HAIFA K080124 01/31/2008
ventri GE MEDICAL SYSTEMS F.I. HAIFA K051855 08/02/2005
spectef protocol GE MEDICAL SYSTEMS K954874 02/26/1996
qps/bpgs/moco processing applications for entegra workstation GE MEDICAL SYSTEMS F.I. HAIFA K003264 12/21/2000
q. freeze (motion vue2) GE MEDICAL SYSTEMS, LLC K113408 02/24/2012
phoenix plus & base nuclear medicine single detector systems GE MEDICAL SYSTEMS K951144 07/03/1995
pet vcar GE Medical Systems SCS K211247 07/27/2021
pet digital gating GE Medical Systems, LLC K180318 04/11/2018
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