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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: KPS Applicant: GE MEDICAL SYSTEMS F.I. HAIFA Decision Date To: 01/24/2021
 
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vpc-94 ultra high energy collimaters model numbers 480-685-9402 GE MEDICAL SYSTEMS F.I. HAIFA K981352 07/13/1998
vtransact: attenuation correction system for dual-head variable angle gamma camera GE MEDICAL SYSTEMS F.I. HAIFA K980959 06/04/1998
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
hawkeye option for dual-head variable angle gamma camera GE MEDICAL SYSTEMS F.I. HAIFA K991841 08/26/1999
mg atc: attenuation correction system for dual-head variable-angle gamma camera GE MEDICAL SYSTEMS F.I. HAIFA K991896 08/23/1999
qps/bpgs/moco processing applications for entegra workstation GE MEDICAL SYSTEMS F.I. HAIFA K003264 12/21/2000
ge photon energy recovery (per) option GE MEDICAL SYSTEMS F.I. HAIFA K023932 12/11/2002
ge quasar nuclear medicine system GE MEDICAL SYSTEMS F.I. HAIFA K022960 09/19/2002
myolight GE MEDICAL SYSTEMS F.I. HAIFA K033874 12/30/2003
infinia lightspeed GE MEDICAL SYSTEMS F.I. HAIFA K043381 12/23/2004
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