FDA.reportPublic FDA data

GE Healthcare Coils

Matched from indexed company URL: GE Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15290413005214683GE Healthcare Coils1N2026-01-011515 DANNER DR AURORA OH US 44202
96101053002806783GE HEALTHCARE FINLAND OY1N2026-01-01KUORTANEENKATU 2 HELSINKI Uusimaa FI FIN-00510
30044973543004497354GE Healthcare GmbH1N2026-01-01Oskar-Schlemmer-Str. 11 Munich Bavaria DE 80807
30045266083004526608GE HEALTHCARE1Y2026-01-01500 W. Monroe Street Chicago IL US 60661
30053269703005326970GE Healthcare Manufacturing LLC1Y2026-01-013001 W RADIO DR FLORENCE SC US 29501
30071203363007120336GE Healthcare Magyarorszag Kft.1N2026-01-01Bence utca 3 Budapest HU 1138
30082844703008284470GE Healthcare (China) Co., Ltd.1N2026-01-011F-5F BLD 1, No.1 Tongji South Road Beijing Economic-Technological Development Area Beijing CN 100176
30109496423010949642GE HEALTHCARE (TIANJIN) COMPANY LIMITED1N2026-01-01No. 266 Jingsan Road Tianjin Airport Economic Area Tianjin CN 300308
30153294233015329423GE Healthcare Manufacturing LLC1N2026-01-013280 General Williams W. Dr. Florence SC US 29506
29150561417338GE HEALTHCARE1N2020-04-253350 N RIDGE AVE ARLINGTON HEIGHTS IL US 60004

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266511529812695K994345MAGNA 5000 PHASED ARRAY CTL SPINE COILMOS2000-02-14
266512007275692K994040PHASED ARRAY KNEE AND FOOT COILMOS2000-01-18
1996891375092983K993645CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMJAK1999-12-21
1996891078857097K993090SILHOUETTE FCKPR1999-10-01
1996891786644507K992746SIGNA HFO/I MAGNETIC RESONANCE SYSTEMLNH1999-11-09
266201397809591K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESMLD1999-11-01
1996891212600386K992135SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEMLNH1999-09-08
266511774966627K983143MARK 5000 PHASED ARRAY SHOULDER COILMOS1998-11-16
1996891963176997K982955SILHOUETTE VRKPR1998-11-04
1996891143597490K982196DIGITAL RADIOGRAPHIC IMAGING SYSTEMKPR1998-10-06
266201672635337K981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1DRT1998-11-03
266511686591810K980157PREMIER 7000 CTL SPINE COILMOS1998-04-13
266511983638837K972340INSIGHT 7000 PHASED ARRAY TORSO COILMOS1997-08-21
266511197037114K971667CARDIAC PHASED ARRAY COILMOS1997-07-23
1996891222523516K964370MAGNETIC RESONANCE DIAGNOSTIC SYSTEMLNH1997-01-10
1996891815348305K950973MAGNETIC RESONANCE DIAGNOSTIC SYSTEMLNH1995-05-11
1996891903982546K945730SIGNA PROFILELNH1995-08-09
1996891336178899K944967TOMO-LINKIZF1994-12-09
1996891480893543K944013CT PROSPEED FAMILYJAK1995-02-07
1996891055268705K931460VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEMLNH1994-03-04
266201915753094K931422DELTATRAC(TM) II METABOLIC MONITORBZL1993-11-24
266511808495795K923264GENERAL PURPOSE FLEX COILLNH1992-09-30
1996891241998845K921653VECTRA MAGNETIC RESONANCE SYSTEMLNH1992-12-24
266201205918838K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSCAN1992-05-27
1996891918812393K913673VECTRA MAGNETIC RESONANCE SYSTEMLNH1992-01-23
1996891036943172K912881GE MR MAXLNH1991-09-06
266511590389999K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYLNH1991-06-28
266202023957244K904355CARDIOCAP II TM CH-RESP MONITORSDPS1991-05-23
1996892069164178K895794GE MR MAX SYSTEMLNH1989-11-17
1996891033308024K894142ULTRANET-S COLLIMATORIZW1989-11-06
1996891153696947K884930COMPAX MODEL 40, 400, 400TIZZ1988-12-22
1996891707133145K883547GE MR MAX SYSTEMLNH1988-11-30
1996891667251860K827928VRT TABLEIZZ1982-09-29
266121062007915K253780SIGNA™ BoltLNH2026-02-06
266511062007915K253780SIGNA™ BoltLNH2026-02-06
1737121062007915K253780SIGNA™ BoltLNH2026-02-06
2284541062007915K253780SIGNA™ BoltLNH2026-02-06
266121472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
1737121472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
1996891472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
2284541472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
266511657166684K2537383.0T AIR 32CH HNAMOS2026-01-23
265511688773155K253639ViewLLZ2026-01-08
1996891041606167K253269OEC One CFDOXO2025-11-26
266121186493886K252379AIR Recon DLLNH2025-12-23
1737121186493886K252379AIR Recon DLLNH2025-12-23
2284541186493886K252379AIR Recon DLLNH2025-12-23
266121186517738K251399SIGNA™ SprintLNH2025-09-11
266511186517738K251399SIGNA™ SprintLNH2025-09-11
1737121186517738K251399SIGNA™ SprintLNH2025-09-11
1996891186517738K251399SIGNA™ SprintLNH2025-09-11
2284541186517738K251399SIGNA™ SprintLNH2025-09-11
1996891652607470K250941Revolution VibeJAK2025-08-01
1996891110546406K250788Definium Tempo SelectKPR2025-08-28
1737121932677102K250379SIGNA Prime EliteLNH2025-03-17
1996891932677102K250379SIGNA Prime EliteLNH2025-03-17
266121589397737K243667Sonic DLLNH2025-06-05
1737121589397737K243667Sonic DLLNH2025-06-05
2284541589397737K243667Sonic DLLNH2025-06-05
265511256009598K242925MR Contour DLQKB2025-04-01
901171256009598K242925MR Contour DLQKB2025-04-01
1996892046382696K242678Definium Pace Select ETKPR2024-10-01
266641217191432K241300ViewPoint 6LLZ2024-07-02
1996891974901503K240828OEC One ASDOXO2024-12-27
266202034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
1996891902267639K233749Revolution Ascend SlidingJAK2024-02-22
266121139154935K233728SIGNA ChampionLNH2024-01-19
1737121139154935K233728SIGNA ChampionLNH2024-01-19
1996891139154935K233728SIGNA ChampionLNH2024-01-19
2284541139154935K233728SIGNA ChampionLNH2024-01-19
265511205645253K232346Digital Expert Access with Remote ScanningLNH2023-10-27
1996891531346436K231892Definium Pace SelectKPR2023-09-12
266201743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
266201175583964K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™MWI2023-08-11
266201423213164K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)MHX2023-04-06
266121329549010K223523Sonic DLLNH2023-05-30
1737121329549010K223523Sonic DLLNH2023-05-30
2284541329549010K223523Sonic DLLNH2023-05-30
266121405955190K223439SIGNA VictorLNH2023-02-13
1737121405955190K223439SIGNA VictorLNH2023-02-13
1996891405955190K223439SIGNA VictorLNH2023-02-13
266511357512220K2233783.0T 16ch AIR AAMOS2023-01-03
265511279198482K222586Mural Clinical ViewerMHX2022-12-21
265511967980478K220732Mural Perinatal SurveillanceHGM2022-06-23
266121537040006K213717AIR Recon DLLNH2022-06-08
1737121537040006K213717AIR Recon DLLNH2022-06-08
2284541537040006K213717AIR Recon DLLNH2022-06-08
1996891074908898K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex editionJAK2021-12-17
266121000118468K213709SIGNA PET/MROUO2022-01-20
1737121000118468K213709SIGNA PET/MROUO2022-01-20
2284541000118468K213709SIGNA PET/MROUO2022-01-20
266121251871082K213668SIGNA HeroLNH2022-01-20
1737121251871082K213668SIGNA HeroLNH2022-01-20
1996891251871082K213668SIGNA HeroLNH2022-01-20
2284541251871082K213668SIGNA HeroLNH2022-01-20
266121274328992K213603SIGNA Artist EvoLNH2022-02-11
1737121274328992K213603SIGNA Artist EvoLNH2022-02-11
1996891274328992K213603SIGNA Artist EvoLNH2022-02-11
2284541274328992K213603SIGNA Artist EvoLNH2022-02-11
266201771137171K213363CARESCAPE B450, E-musbMHX2022-04-13
266201171121298K213336Carescape B850, E-musbMHX2022-04-13
266201481395238K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHX2022-04-12
266201513812715K213181CARESCAPE B650, E-musbMHX2022-04-13
266121295749543K211980SIGNA PrimeLNH2022-01-16
1737121295749543K211980SIGNA PrimeLNH2022-01-16
1996891295749543K211980SIGNA PrimeLNH2022-01-16
265511255482483K211841MRI PlannerMUJ2022-08-25
265511776385446K211312Universal ViewerLLZ2021-05-21
266201510858541K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessoriesCCK2021-10-21
266121788023801K211118SIGNA 7.0TLNH2021-05-13
266641659562096K203677ViewPoint 6LLZ2021-01-15
1996891596378264K203617MaxFOV 2JAK2021-03-02
266121147438985K202966SIGNA ArchitectLNH2020-11-13
1737121147438985K202966SIGNA ArchitectLNH2020-11-13
2284541147438985K202966SIGNA ArchitectLNH2020-11-13
266121186609949K202238SIGNA ArtistLNH2020-09-04
1737121186609949K202238SIGNA ArtistLNH2020-09-04
1996891186609949K202238SIGNA ArtistLNH2020-09-04
2284541186609949K202238SIGNA ArtistLNH2020-09-04
266121208062311K201615SIGNA 7.0TLNH2020-10-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH1692026-02-06
MOS492026-01-23
LLZ302026-01-08
MHX292023-04-06
JAK262025-08-01
KPR132025-08-28
OUO112022-01-20
DQA92013-09-27
OXO72025-11-26
CCK72021-10-21
OLW62015-11-12
BSZ62011-06-10
MSX62007-03-13
DQK42023-12-13
DPS42014-01-23
HGM32022-06-23
OWB32018-11-02
QKB22025-04-01
MWI22024-03-20
OLT22020-01-22
IZF22013-11-18
CCL22013-02-28
MQB22010-11-18
GXY22008-11-28
MLD22001-09-14
IZZ21988-12-22
MUJ12022-08-25
DXG12014-01-16
KXH12012-11-16
IZI12011-07-26
GWQ12011-07-19
IZL12011-06-16
DSI12008-05-19
KOI12005-07-15
DPZ12004-09-02
DRT11998-11-03
BZL11993-11-24
CAN11992-05-27
IZW11989-11-06

NDC#

PMA#

42 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#

50 records. Showing 1-40. Next

GUDID#