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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96132993004571294GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING1N2027-01-014 HAYOZMA ST. TIRAT HACARMEL Haifa IL 30200
30335242513033524251GE Medical Systems Israel, Functional Imaging1N2027-01-01Ha Peles 18 Haifa IL 26289

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266691280000002K994167CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)KPS2000-03-07
266691217983840K991896MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERAKPS1999-08-23
266691671971920K991841HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAKPS1999-08-26
266691959257878K981352VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402KPS1998-07-13
266691571508207K980959VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAKPS1998-06-04
266691014793229K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSKPS1996-10-10
266691900946764K962100VOLMETRIC COINCIDENCE DETECTION SYSTEMKPS1997-01-10
266691047873095K953801VARICAMKPS1995-11-22
266691903785707K952674TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERAKPS1995-09-26
266691414492008K951144PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMSKPS1995-07-03
266691615791043K942837DST-XLKPS1995-01-05
266691290320814K932673APEX SPX CARDIALIYX1994-02-18
266691201105972K914807APEX HELIX - AKPS1992-02-27
266692024609831K884675APEX 609R ANGER CAMERAIYX1989-04-17
266691148964187K884674APEX 415 ANGER CAMERAIYX1989-04-17
266691410923542K251153AuroraKPS2025-06-12
3329531410923542K251153AuroraKPS2025-06-12
3329531409357724K243605AuroraKPS2025-01-17
266691409357724K243605AuroraKPS2025-01-17
266691201360968K241665Omni LegendKPS2024-08-08
3329531201360968K241665Omni LegendKPS2024-08-08
266691634743929K241350Clarify DLLLZ2025-01-03
266691046460269K223212Precision DLKPS2023-04-27
266691185445219K221932Omni LegendKPS2022-09-02
3329531185445219K221932Omni LegendKPS2022-09-02
266691379010043K221680Xeleris V Processing and Review SystemLLZ2023-03-01
266691378986928K212004MyoSPECT, MyoSpect ESKPS2021-08-27
3329531378986928K212004MyoSPECT, MyoSpect ESKPS2021-08-27
266691959088785K211846Discovery MI Gen2KPS2021-08-20
266691950207815K210173StarGuideKPS2021-03-29
3329531950207815K210173StarGuideKPS2021-03-29
266691690336946K201103Xeleris V Processing and Review SystemsLLZ2020-09-25
266691300875194K180318PET Digital GatingKPS2018-04-11
3329531155765179K173816NM/CT 850, NM/CT 860KPS2018-04-17
266691155765179K173816NM/CT 850, NM/CT 860KPS2018-04-17
266691745678756K161574Discovery MIKPS2016-08-11
266691577780573K160933Discovery NM 750b BopsyIYX2016-11-18
266691636571163K153402Discovery NM/CT 670 CZTKPS2016-01-21
3329531636571163K153402Discovery NM/CT 670 CZTKPS2016-01-21
266691461552988K153355Xeleris 4.0 Processing and Review WorkstationLLZ2016-03-16
266691207496007K151372Low Dose CT Lung Cancer Screening Option for Qualified GE SystemsJAK2015-08-14
266691831643512K141477DISCOVERY IQKPS2014-09-18
266691824266539K133657DISCOVERY PET/CT 710KPS2014-03-21
266692007871666K130884XELERIS 3.1 PROCESSING AND REVIEW WORKSTATIONLLZ2013-04-12
266691223468959K121019OPTIMA NM/CT 640KPS2012-04-19
3329531223468959K121019OPTIMA NM/CT 640KPS2012-04-19
266691286822982K113350BRIVO NM 615KPS2011-12-05
266691718531484K111445DISCOVERY NM 630KPS2011-06-03
3329531718531484K111445DISCOVERY NM 630KPS2011-06-03
266691486210684K102231DISCOVERY NM 750BIYX2010-11-03
266691711189627K093982XELERIS 3 PROCESSING AND REVIEW WORKSTATIONLLZ2010-01-08
266691656157457K093514DISCOVERY MODEL NM/CT 670KPS2009-12-10
3329531656157457K093514DISCOVERY MODEL NM/CT 670KPS2009-12-10
266691621495099K083504GE DISCOVERY NM/CT 570CKPS2008-12-12
266691084995480K080124VENTRI 1.1KPS2008-01-31
266691686269039K052434HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAKPS2005-09-27
266691137676818K051855VENTRIKPS2005-08-02
266691795327567K051673XELERIS 2 PROCESSING AND REVIEW WORKSTATIONLLZ2005-07-18
266691423182991K024137JUPITER PROCESSING AND REVIEW WORKSTATIONLLZ2003-01-15
266691555680445K023932GE PHOTON ENERGY RECOVERY (PER) OPTIONKPS2002-12-11
266691246476584K022960GE QUASAR NUCLEAR MEDICINE SYSTEMKPS2002-09-19
266691253821379K003264QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATIONKPS2000-12-21
266691865443938K000395EINSTEIN PROCESSING AND REVIEW WORKSTATIONLLZ2000-05-03
266691303950144
266691391193274
3329531391193274
266691690531055
3329531690531055
266691721458432

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS482025-06-12
LLZ92025-01-03
IYX52016-11-18
JAK12015-08-14

PMN#

GUDID#