FDA.report

GE Healthcare Coils

Matched from indexed company URL: GE Healthcare

FDA Registration(s)

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
96122833002808529GE Healthcare Japan Corporation1N2026-01-017-127, Asahigaoka 4-chome HINO-SHI Tokyo JP 191-8503
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

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00840682145558Centricity - CPACS 7.0+1(800)437-1171xx@xx.xx

Registered Device Listings

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
266051994938556K991716HISPEED NX/I CT SCANNER SYSTEMJAK1999-06-18
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
266051667739365K980176HISPEED QX/I CT SCANNER SYSTEMJAK1998-04-13
266051288921104K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMSJAK1998-04-13
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
266051147122009K963896MOBILE CT PROSPEED FAMILYJAK1996-12-18
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
266051812425088K921192CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEMJAK1992-10-20
266201205918838K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSCAN1992-05-27
1996891918812393K913673VECTRA MAGNETIC RESONANCE SYSTEMLNH1992-01-23
266051686113718K913485CT SYTEC 8000JAK1992-01-23
1996891036943172K912881GE MR MAXLNH1991-09-06
266511590389999K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYLNH1991-06-28
266051254576328K911387CT SYTEC 4000JAK1991-05-09
266202023957244K904355CARDIOCAP II TM CH-RESP MONITORSDPS1991-05-23
1996892069164178K895794GE MR MAX SYSTEMLNH1989-11-17
1996891033308024K894142ULTRANET-S COLLIMATORIZW1989-11-06
266051717034491K893820CT SYTEC 3000JAK1989-08-07
1996891153696947K884930COMPAX MODEL 40, 400, 400TIZZ1988-12-22
1996891707133145K883547GE MR MAX SYSTEMLNH1988-11-30
266051532268600K882581CT MAX 640 #B7940 JA/JEJAK1988-08-15
266051861477927K872526CT PACE CATALOG NUMBER B7950AJAK1987-09-23
266051508641653K862317CT MAX, CATALOG NO. B7940 HAJAK1986-10-07
266051474458767K843927CT 9000JAK1984-12-17
1996891667251860K827928VRT TABLEIZZ1982-09-29
266051228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
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
266051119048953K253686True Definition DLJAK2026-03-23
265511688773155K253639ViewLLZ2026-01-08
266051695495357K253370LOGIQ TotusIYN2026-01-08
266051684322365K253366LOGIQ FortisIYN2026-01-07
1996891041606167K253269OEC One CFDOXO2025-11-26
266121186493886K252379AIR Recon DLLNH2025-12-23
1737121186493886K252379AIR Recon DLLNH2025-12-23
2284541186493886K252379AIR Recon DLLNH2025-12-23
266051111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266052053695773K251985LOGIQ E10IYN2025-10-29
266051078030117K251963LOGIQ E10sIYN2025-10-29
266121186517738K251399SIGNA™ SprintLNH2025-09-11
266511186517738K251399SIGNA™ SprintLNH2025-09-11
1737121186517738K251399SIGNA™ SprintLNH2025-09-11
1996891186517738K251399SIGNA™ SprintLNH2025-09-11
2284541186517738K251399SIGNA™ SprintLNH2025-09-11
266051846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266051040314840K251169Vivid PioneerIYN2025-07-10
1996891652607470K250941Revolution VibeJAK2025-08-01
1996891110546406K250788Definium Tempo SelectKPR2025-08-28
266051833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
1737121932677102K250379SIGNA Prime EliteLNH2025-03-17
1996891932677102K250379SIGNA Prime EliteLNH2025-03-17
266121589397737K243667Sonic DLLNH2025-06-05
1737121589397737K243667Sonic DLLNH2025-06-05
2284541589397737K243667Sonic DLLNH2025-06-05
266051273874788K243628Vivid T9/Vivid T8IYN2025-02-11
266051905736941K243620Vivid iqIYN2025-02-11
265511256009598K242925MR Contour DLQKB2025-04-01
901171256009598K242925MR Contour DLQKB2025-04-01
1996892046382696K242678Definium Pace Select ETKPR2024-10-01
266051519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
266051955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
266641217191432K241300ViewPoint 6LLZ2024-07-02
1996891974901503K240828OEC One ASDOXO2024-12-27
266051829127751K240111VenueIYN2024-06-10
266051060568579K240053Venue GoIYN2024-06-10
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
266051574908925K234106Venue FitIYN2024-06-10
1996891902267639K233749Revolution Ascend SlidingJAK2024-02-22
266121139154935K233728SIGNA ChampionLNH2024-01-19
1737121139154935K233728SIGNA ChampionLNH2024-01-19
1996891139154935K233728SIGNA ChampionLNH2024-01-19
2284541139154935K233728SIGNA ChampionLNH2024-01-19
266051921203345K233698True Enhance DLJAK2024-04-11
266051414324903K233692Voluson Signature 20, Voluson Signature 18IYN2024-03-07
266051233237274K232381LOGIQ TotusIYN2023-12-07
265511205645253K232346Digital Expert Access with Remote ScanningLNH2023-10-27
266051507556663K232186LOGIQ eIYN2023-11-03
266051680768656K231989LOGIQ E10s, LOGIQ FortisIYN2023-11-07
266051803846471K231966LOGIQ E10IYN2023-11-07
266051113056635K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2023-10-30
1996891531346436K231892Definium Pace SelectKPR2023-09-12
266201743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
266051504428246K230807Deep Learning Image ReconstructionJAK2023-04-20
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
266051146882666K230346Voluson SWIFT; Voluson SWIFT+IYN2023-06-20
266051550945944K223832Vivid S60N, Vivid S70NIYN2023-02-16
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
266051484427763K223407Versana EssentialIYN2023-02-15

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LNH1722026-02-06
IYN1492026-03-24
JAK592026-03-23
MOS482023-01-03
LLZ302026-01-08
MHX292023-04-06
KPR132025-08-28
OUO112022-01-20
DQA92013-09-27
IYO82012-04-19
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
ITX32012-10-05
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
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

NDC

Optison

GE Healthcare Inc.

Human Albumin Microspheres and Perflutren

Flyrcado

GE Healthcare Inc.

FLURPIRIDAZ F-18

Vizamyl

GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)

Flutemetamol F-18

CERIANNA

GE Healthcare Inc.

FLUOROESTRADIOL F 18

PMA

42 records. Showing 1-40. Next

PMN

SIGNA Victor

2023-02-13

Ge Healthcare (Tianjin) Company Limited

SIGNA Hero

2022-01-20

GE Healthcare (GE Medical Systems, LLC)

SIGNA Prime

2022-01-16

GE Healthcare (Tianjin) Company Limited

SIGNA Artist

2020-09-04

GE Healthcare (Tianjin) Company Limited

200 records. Showing 1-40. Next

Applications

50 records. Showing 1-40. Next

GUDID