FDA.reportPublic FDA data

GE Healthcare Coils

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15290413005214683GE Healthcare Coils1N2026-01-011515 DANNER DR AURORA OH US 44202

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
266511774966627K983143MARK 5000 PHASED ARRAY SHOULDER COILMOS1998-11-16
266511686591810K980157PREMIER 7000 CTL SPINE COILMOS1998-04-13
266511983638837K972340INSIGHT 7000 PHASED ARRAY TORSO COILMOS1997-08-21
266511197037114K971667CARDIAC PHASED ARRAY COILMOS1997-07-23
266511808495795K923264GENERAL PURPOSE FLEX COILLNH1992-09-30
266511590389999K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYLNH1991-06-28
266511062007915K253780SIGNA™ BoltLNH2026-02-06
266511186517738K251399SIGNA™ SprintLNH2025-09-11
266511357512220K2233783.0T 16ch AIR AAMOS2023-01-03
266511147416358K192426Signa Voyager, Signa Voyager QuantumLNH2019-10-01
266511011301492K1825901.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AAMOS2018-10-19
266511075891373K1825043.0T Air MP M, 3.0T Air MP LMOS2018-10-12
266511609112959K18066648CH Head CoilMOS2018-04-12
266511371053248K172695AIR Anterior Array, AIR Posterior ArrayMOS2017-11-22
266511997384387K163619SIGNA PET/MROUO2017-02-14
266511353826573K16320548CH Head CoilMOS2017-01-12
266511677996714K161567SIGNA VoyagerLNH2016-09-01
266511985183816K160621SIGNAPioneerLNH2016-03-29
266511395401869K153003SIGNA PioneerLNH2015-10-27
266511039159618K1433893.0T GEM RT Open ArrayMOS2015-03-06
266511576267454K143345SIGNA PioneerLNH2015-07-10
266511515240807K143251SIGNA Creator, SIGNA ExplorerLNH2015-02-04
266512009690707K142098SIGNA PET/MROUO2014-11-24
266511199830746K1236811.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COILMOS2013-02-22
266511467218663K123417BRIVO MR355, OPTIMA MR360LNH2013-01-17
266511103087178K1233271.5T GEM RT OPEN ARRAYMOS2013-01-11
266511582121596K122174PEDIATRIC POSITIONER PAD SETKXH2012-11-16
266511510863412K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
266511391587162K103365DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY AMOS2011-01-12
266511522077667K103335GEM OPTION FOR 1.5 MRI SYSTEMSMOS2011-03-07
266511344036197K103330BRIVO MR355, OPTIMA MR360LNH2011-02-11
266511559491203K103327DISCOVERY MR750W 3.0TLNH2011-09-30
266511920934673K1014928 CHANNEL CARDIAC PHASED ARRAY COILMOS2010-06-23
266511626239153K0933483.0T 16 CHANNEL HEAD NECK SPINE COILMOS2009-11-25
266511699168798K083147DISCOVERY MR450LNH2008-11-04
266511286127436K081028SIGNA 3.0T MR750 SYSTEMLNH2008-04-25
266511509203389K052978GE 1.5T SIGNA HDE MR SYSTEMLNH2005-11-09
266511539741056K0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COILMOS2005-10-07
266511246033859K0525853T HD BREAST ARRAYMOS2005-10-04
266511863860361K0525841.5T 12 CHANNEL BODY ARRAYMOS2005-10-07
266511144134277K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMLNH2005-09-21
266511949472624K042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COILMOS2004-09-24
266511480123415K04220711000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COILMOS2004-08-26
266511391488434K042009MARK III PHASED ARRAY SHOULDER COILMOS2004-08-11
266511609665491K041695LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATELNH2004-07-23
266511850564884K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17
266511956826255K0325383.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COILMOS2003-09-12
266511652412550K0324743.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COILMOS2003-08-25
266511846787650K0320458 CHANNEL CARDIAC PHASED ARRAY COILMOS2003-07-30
266511097045036K031366PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COILMOS2003-07-11
266512000958696K031209GE 1.5T 8 CHANNEL TORSO COILMOS2003-05-23
266511879808574K031172SPIRIT III TOTALSENSE CARDIAC COILMOS2003-05-29
266511469114514K031139PREMIER III PHASED ARRAY CTL SPINE COILMOS2003-05-29
266511327814682K030953GE 3.0T GENERAL PURPOSE FLEX COILMOS2003-04-10
266511389539235K0304953.0T TORSO PHASED ARRAY COILMOS2003-03-05
266511605261628K030371PRIMA III TOTALSENSE TORSO COILMOS2003-05-05
266511813445012K021141MILLENNIUM 5000 MEUROVASCULAR COILMOS2002-06-27
266511848977563K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYLNH2002-01-24
266511808154076K010946MARK 9000 PHASED ARRAY SHOULDER COILMOS2001-05-30
266511350424146K001870MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COILMOS2000-08-14
266511775993494K001582LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATEMOS2000-07-17
266511849734223K000437INTERVENTIONAL BODY COILMOS2000-04-14
266511475638643K000002MAGNA 5000 PHASED ARRAY CTL SPINE COILMOS2000-02-23
266511229639242

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS412023-01-03
LNH212026-02-06
OUO22017-02-14
KXH12012-11-16

PMN#