FDA.reportPublic FDA data

GE Healthcare Manufacturing LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053269703005326970GE Healthcare Manufacturing LLC1Y2026-01-013001 W RADIO DR FLORENCE SC US 29501
30153294233015329423GE Healthcare Manufacturing LLC1N2026-01-013280 General Williams W. Dr. Florence SC US 29506

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2284541062007915K253780SIGNA™ BoltLNH2026-02-06
266121062007915K253780SIGNA™ BoltLNH2026-02-06
2284541472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
266121472642476K253779SIGNA™ Sprint SelectLNH2026-02-05
2284541186493886K252379AIR Recon DLLNH2025-12-23
266121186493886K252379AIR Recon DLLNH2025-12-23
266121186517738K251399SIGNA™ SprintLNH2025-09-11
2284541186517738K251399SIGNA™ SprintLNH2025-09-11
2284541589397737K243667Sonic DLLNH2025-06-05
266121589397737K243667Sonic DLLNH2025-06-05
266121139154935K233728SIGNA ChampionLNH2024-01-19
2284541139154935K233728SIGNA ChampionLNH2024-01-19
266121329549010K223523Sonic DLLNH2023-05-30
2284541329549010K223523Sonic DLLNH2023-05-30
266121405955190K223439SIGNA VictorLNH2023-02-13
266121537040006K213717AIR Recon DLLNH2022-06-08
2284541537040006K213717AIR Recon DLLNH2022-06-08
2284541000118468K213709SIGNA PET/MROUO2022-01-20
266121000118468K213709SIGNA PET/MROUO2022-01-20
2284541251871082K213668SIGNA HeroLNH2022-01-20
266121251871082K213668SIGNA HeroLNH2022-01-20
2284541274328992K213603SIGNA Artist EvoLNH2022-02-11
266121274328992K213603SIGNA Artist EvoLNH2022-02-11
266121295749543K211980SIGNA PrimeLNH2022-01-16
266121788023801K211118SIGNA 7.0TLNH2021-05-13
2284541147438985K202966SIGNA ArchitectLNH2020-11-13
266121147438985K202966SIGNA ArchitectLNH2020-11-13
266121186609949K202238SIGNA ArtistLNH2020-09-04
2284541186609949K202238SIGNA ArtistLNH2020-09-04
266121208062311K201615SIGNA 7.0TLNH2020-10-15
2284541433782973K193282SIGNA PremierLNH2020-04-10
266121433782973K193282SIGNA PremierLNH2020-04-10
266121147416358K192426Signa Voyager, Signa Voyager QuantumLNH2019-10-01
2284541943209179K183231SIGNA PremierLNH2019-01-18
266121943209179K183231SIGNA PremierLNH2019-01-18
266121069540375K171128SIGNA PremierLNH2017-07-14
2284541069540375K171128SIGNA PremierLNH2017-07-14
266121997384387K163619SIGNA PET/MROUO2017-02-14
2284541997384387K163619SIGNA PET/MROUO2017-02-14
2284541095301138K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistLNH2017-03-17
266121095301138K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistLNH2017-03-17
266121677996714K161567SIGNA VoyagerLNH2016-09-01
2284541677996714K161567SIGNA VoyagerLNH2016-09-01
2284541985183816K160621SIGNAPioneerLNH2016-03-29
266121985183816K160621SIGNAPioneerLNH2016-03-29
2284541503528666K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TLNH2016-06-09
266121503528666K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TLNH2016-06-09
2284541395401869K153003SIGNA PioneerLNH2015-10-27
266121395401869K153003SIGNA PioneerLNH2015-10-27
266121576267454K143345SIGNA PioneerLNH2015-07-10
2284541576267454K143345SIGNA PioneerLNH2015-07-10
266121515240807K143251SIGNA Creator, SIGNA ExplorerLNH2015-02-04
2284541515240807K143251SIGNA Creator, SIGNA ExplorerLNH2015-02-04
266122009690707K142098SIGNA PET/MROUO2014-11-24
2284542009690707K142098SIGNA PET/MROUO2014-11-24
266121510863412K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
2284541510863412K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
2284541196014947K113490OPTIMA MR450WLNH2012-01-13
266121196014947K113490OPTIMA MR450WLNH2012-01-13
2284541344036197K103330BRIVO MR355, OPTIMA MR360LNH2011-02-11
266121344036197K103330BRIVO MR355, OPTIMA MR360LNH2011-02-11
2284541559491203K103327DISCOVERY MR750W 3.0TLNH2011-09-30
266121559491203K103327DISCOVERY MR750W 3.0TLNH2011-09-30
266121076215011K102155MR RADIATION ONCOLOGY OPTIONSLNH2010-08-31
2284541384819507K091536OPTIMA MR450WLNH2009-07-17
266121384819507K091536OPTIMA MR450WLNH2009-07-17
2284541699168798K083147DISCOVERY MR450LNH2008-11-04
266121699168798K083147DISCOVERY MR450LNH2008-11-04
266121179911121K081916GE SIGNA MR ONCOLOGY PACKAGELNH2008-07-22
266121286127436K081028SIGNA 3.0T MR750 SYSTEMLNH2008-04-25
2284541286127436K081028SIGNA 3.0T MR750 SYSTEMLNH2008-04-25
266121509203389K052978GE 1.5T SIGNA HDE MR SYSTEMLNH2005-11-09
2284541509203389K052978GE 1.5T SIGNA HDE MR SYSTEMLNH2005-11-09
266121144134277K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMLNH2005-09-21
2284541144134277K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMLNH2005-09-21
266121403713142K043262GE SIGNA EXCITE MR SURGICAL OPTIONLNH2005-01-12
266121850564884K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17
2284541850564884K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH722026-02-06
OUO62022-01-20