GE MEDICAL SYSTEMS, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2122726	1000116747	GE MEDICAL SYSTEMS, LLC	1	N	2026-01-01	4855 West Electric Avenue Milwaukee WI US 53219
2126677	2126677	GE MEDICAL SYSTEMS, LLC	1	Y	2026-01-01	3000 N GRANDVIEW BLVD. Waukesha WI US 53188
2183553	2183553	GE MEDICAL SYSTEMS, LLC	1	N	2026-01-01	3200 N GRANDVIEW BLVD WAUKESHA WI US 53188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
26607	1089787345	K993665	LEGEND CRF FLUORO AND RAD SYSTEM	KPR	1999-11-12
26607	1078857097	K993090	SILHOUETTE FC	KPR	1999-10-01
26607	1143597490	K982196	DIGITAL RADIOGRAPHIC IMAGING SYSTEM	KPR	1998-10-06
26606	1518399848	K981190	HIGH IMPEDANCE CARDIAC GATING CABLE	LNH	1998-06-30
26607	1199830541	K973168	SMARTVIEW OPTIONS FOR HISPEED CT/I	JAK	1997-11-21
26607	1712025503	K973039	LEGACY/LEGACY-D TABLE	IXR	1997-10-16
26606	1197037114	K971667	CARDIAC PHASED ARRAY COIL	MOS	1997-07-23
26607	1310249920	K964746	HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION	JAK	1997-01-24
26606	1805200714	K962061	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	LNH	1996-11-27
26606	1647162663	K960265	ADVANTAGE WINDOWS WITH FUNCTOOL OPTION	LLZ	1996-07-03
26607	1647162663	K960265	ADVANTAGE WINDOWS WITH FUNCTOOL OPTION	LLZ	1996-07-03
26606	1303578194	K953595	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	MOS	1995-10-27
26607	1017157219	K950317	ADVANTX 1824 SPOTFILM DEVICE	IXL	1995-02-08
26607	1336178899	K944967	TOMO-LINK	IZF	1994-12-09
26607	1065452841	K943805	PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD	JAA	1994-09-23
26607	1951622246	K936180	TC+ SYSTEM (TILTING C-ARM SYSTEM)	OWB	1994-03-16
26607	1457478268	K924310	PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC	LLZ	1993-01-21
26607	1324907077	K923309	ARGUS PET SYSTEM	KPS	1992-09-29
26606	1808495795	K923264	GENERAL PURPOSE FLEX COIL	LNH	1992-09-30
26606	1590389999	K911806	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	LNH	1991-06-28
26607	1423501434	K910902	VMX MOBILE X-RAY SYSTEM	IZL	1991-09-09
26607	1634715199	K902989	G.E. MONITROL 90 AND G.E. MONITROL 15	IXR	1990-10-29
26607	1033308024	K894142	ULTRANET-S COLLIMATOR	IZW	1989-11-06
26607	1153696947	K884930	COMPAX MODEL 40, 400, 400T	IZZ	1988-12-22
26607	1913035631	K862120	SCX SYSTEM	JAA	1986-06-16
26607	1904882389	K843926	PRESTILIX 1690	IXR	1984-12-17
26607	1667251860	K827928	VRT TABLE	IZZ	1982-09-29
26607	1547305233	K802047	AMX-III	IZL	1980-10-23
26607	1649810769	K801320	SFX-90 TABLE/SPOTFILMER W/FLUORICON L200	JAA	1980-07-21
26607	2013638259	K760466	TABLE, X-RAY, RFX CLASSICAL	IXR	1976-08-26
26606	1062007915	K253780	SIGNA™ Bolt	LNH	2026-02-06
26607	1119048953	K253686	True Definition DL	JAK	2026-03-23
26607	1680497011	K253560	Enhanced Boundary for PCCT	JAK	2026-06-24
26607	1012066396	K253520	Photonova Spectra, Photonova Spectra Select	JAK	2026-03-20
26607	1480009403	K253502	Critical Care Suite with Enteric Tube Positioning AI Algorithm	QIH	2026-04-14
26606	1186493886	K252379	AIR Recon DL	LNH	2025-12-23
26607	1652607470	K250941	Revolution Vibe	JAK	2025-08-01
26606	1589397737	K243667	Sonic DL	LNH	2025-06-05
26607	1201360968	K241665	Omni Legend	KPS	2024-08-08
26607	1539907557	K233750	ECG-less Cardiac	JAK	2024-04-02
26607	1921203345	K233698	True Enhance DL	JAK	2024-04-11
26607	1504428246	K230807	Deep Learning Image Reconstruction	JAK	2023-04-20
26607	1171563652	K230082	Auto Segmentation	QKB	2023-05-04
26606	1329549010	K223523	Sonic DL	LNH	2023-05-30
26607	1657005371	K223514	Spectral Bone Marrow	JAK	2023-03-09
26607	1859468484	K223491	Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite	QBS	2023-05-25
26607	1046460269	K223212	Precision DL	KPS	2023-04-27
26607	1185445219	K221932	Omni Legend	KPS	2022-09-02
26607	1402135574	K213999	Deep Learning Image Reconstruction	JAK	2022-02-18
26607	1290633536	K213938	Revolution Ascend	JAK	2022-02-04
26606	1537040006	K213717	AIR Recon DL	LNH	2022-06-08
26607	1074908898	K213715	Revolution 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 edition	JAK	2021-12-17
26606	1000118468	K213709	SIGNA PET/MR	OUO	2022-01-20
26606	1251871082	K213668	SIGNA Hero	LNH	2022-01-20
26607	1959088785	K211846	Discovery MI Gen2	KPS	2021-08-20
26606	1255482483	K211841	MRI Planner	MUJ	2022-08-25
26607	1179559812	K211161	Critical Care Suite with Endotracheal Tube Positing AI algorithm	QIH	2021-10-29
26606	1788023801	K211118	SIGNA 7.0T	LNH	2021-05-13
26607	1860639661	K210982	AMX Navigate	IZL	2021-04-28
26607	1596378264	K203617	MaxFOV 2	JAK	2021-03-02
26606	1147438985	K202966	SIGNA Architect	LNH	2020-11-13
26607	1972532789	K201745	Deep Learning Image Reconstruction for Gemstone Spectral Imaging	JAK	2020-12-10
26606	1208062311	K201615	SIGNA 7.0T	LNH	2020-10-15
26606	1433782973	K193282	SIGNA Premier	LNH	2020-04-10
26607	1134405301	K192956	Auto Positioning	JAK	2020-01-16
26607	1847295431	K192686	Revolution Maxima, Revolution Ace	JAK	2019-10-24
26607	1590454665	K191777	Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition	JAK	2019-07-26
26607	1592295961	K191699	Discovery XR656 HD with VolumeRad	KPR	2019-07-24
26606	1943209179	K183231	SIGNA Premier	LNH	2019-01-18
26607	1365834563	K183202	Deep Learning Image Reconstruction	JAK	2019-04-12
26607	2059134781	K183182	Critical Care Suite	QFM	2019-08-12
26607	1838189667	K183161	SnapShot Freeze 2	JAK	2019-02-13
26607	1960268141	K182234	Optima XR240amx	IZL	2018-09-06
26607	1300875194	K180318	PET Digital Gating	KPS	2018-04-11
26607	1467931330	K173612	Optima XR646 HD	KPR	2017-12-11
26607	1694601952	K173602	Optima XR240amx, AutoGrid	IZL	2018-01-12
26607	1178048895	K172869	Discovery XR656 HD	KPR	2017-10-20
26606	1069540375	K171128	SIGNA Premier	LNH	2017-07-14
26606	1997384387	K163619	SIGNA PET/MR	OUO	2017-02-14
26607	1997384387	K163619	SIGNA PET/MR	OUO	2017-02-14
26607	1095301138	K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	LNH	2017-03-17
26606	1095301138	K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	LNH	2017-03-17
26607	1883730630	K163213	Revolution CT	JAK	2016-12-16
26607	1246122195	K162990	Optima XR240amx	IZL	2016-11-15
26606	1798867036	K162722	HyperSense	LNH	2017-04-20
26606	1315631148	K162403	HyperBand	LNH	2016-11-18
26607	1745678756	K161574	Discovery MI	KPS	2016-08-11
26606	1446951074	K161397	MAGiC	LNH	2016-08-31
26606	1985183816	K160621	SIGNAPioneer	LNH	2016-03-29
26606	1503528666	K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T	LNH	2016-06-09
26607	1987358190	K153429	SmartView 3D Option	JAK	2016-03-09
26606	1395401869	K153003	SIGNA Pioneer	LNH	2015-10-27
26607	1207496007	K151372	Low Dose CT Lung Cancer Screening Option for Qualified GE Systems	JAK	2015-08-14
26607	1126872315	K150193	Customer Remote Console (CRC)	LLZ	2015-03-24
26606	1576267454	K143345	SIGNA Pioneer	LNH	2015-07-10
26607	1337480300	K143270	Optima XR646	KPR	2015-02-18
26607	1515240807	K143251	SIGNA Creator, SIGNA Explorer	LNH	2015-02-04
26607	1482715967	K142383	Optima XR200amx, Optima XR220amx	IZL	2014-09-25
26606	1361345260	K142361	Discovery MR750 3.0T	LNH	2014-12-05
26607	2009690707	K142098	SIGNA PET/MR	OUO	2014-11-24
26606	2009690707	K142098	SIGNA PET/MR	OUO	2014-11-24
26606	1321244866	K142085	DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T	LNH	2014-09-26
26607	1831643512	K141477	DISCOVERY IQ	KPS	2014-09-18
26607	1794343647	K141074	CORTEX ID SUITE	KPS	2014-09-18
26607	1902826141	K133705	REVOLUTION CT	JAK	2014-04-11
26607	1824266539	K133657	DISCOVERY PET/CT 710	KPS	2014-03-21
26607	1585358761	K133640	ASIR-V	JAK	2014-03-25
26607	1515159878	K132410	DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W	JAK	2014-01-17
26606	1984470929	K132376	DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T	LNH	2013-11-15
26607	1107717417	K132261	DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)	IZF	2013-11-18
26607	1308711812	K131576	OPTIMA CT660	JAK	2013-08-30
26606	1410969645	K130115	DISCOVERY MR750W 3.0T	LNH	2013-05-23
26607	1167799541	K123596	OPTIMA CT520	JAK	2013-02-08
26606	1730127814	K123522	OPTIMA MR450W	LNH	2013-03-13
26606	1343181065	K123068	OPTIMA MR 430S	LNH	2012-11-13
26607	1958121057	K121827	GSI VIEWER WITH VUE OPTION	JAK	2012-09-13
26606	2068756294	K121762	CARDIAC VX	LLZ	2013-01-18
26606	1510863412	K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	LNH	2012-09-20
26607	1472484347	K120833	DISCOVERY CT750 HD	JAK	2012-06-12
26606	1196014947	K113490	OPTIMA MR450W	LNH	2012-01-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LNH	65	2026-02-06
JAK	48	2026-06-24
KPS	20	2024-08-08
IZL	10	2021-04-28
KPR	9	2019-07-24
MOS	7	2011-04-01
OUO	5	2022-01-20
LLZ	5	2015-03-24
JAA	5	2008-06-11
IXR	4	1997-10-16
QIH	2	2026-04-14
IZF	2	2013-11-18
IZZ	2	1988-12-22
QBS	1	2023-05-25
QKB	1	2023-05-04
MUJ	1	2022-08-25
QFM	1	2019-08-12
MQB	1	2006-11-17
LNI	1	2001-08-22
IXL	1	1995-02-08
OWB	1	1994-03-16
IZW	1	1989-11-06

PMN#

SIGNA? Sprint
2025-09-11
Ge Medical Systems, LLC
Revolution Vibe
2025-08-01
Ge Medical Systems, LLC
SIGNA Prime Elite
2025-03-17
Ge Medical Systems, LLC
SIGNA MAGNUS
2024-10-17
Ge Medical Systems, LLC
ECG-less Cardiac
2024-04-02
Ge Medical Systems, LLC
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
2023-05-25
Ge Medical Systems, LLC
Auto Segmentation
2023-05-04
Ge Medical Systems, LLC
Spectral Bone Marrow
2023-03-09
Ge Medical Systems, LLC
SIGNA PET/MR
2022-01-20
GE Medical Systems, LLC
Critical Care Suite With Endotracheal Tube Positing AI Algorithm
2021-10-29
GE Medical Systems, LLC
SIGNA 7.0T
2021-05-13
GE Medical Systems, LLC
AMX Navigate
2021-04-28
GE Medical Systems, LLC
Deep Learning Image Reconstruction For Gemstone Spectral Imaging
2020-12-10
GE Medical Systems, LLC
SIGNA 7.0T
2020-10-15
GE Medical Systems, LLC
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition
2019-07-26
GE Medical Systems, LLC
SIGNA Premier
2019-01-18
GE Medical Systems, LLC
Optima XR240amx
2018-09-06
GE Medical Systems, LLC
PET Digital Gating
2018-04-11
GE Medical Systems, LLC
Optima XR240amx, AutoGrid
2018-01-12
GE Medical Systems, LLC
SIGNA Premier
2017-07-14
GE Medical Systems, LLC
HyperSense
2017-04-20
GE MEDICAL SYSTEMS, LLC
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect And SIGNA Artist
2017-03-17
GE Medical Systems, LLC
SIGNA PET/MR
2017-02-14
GE Medical Systems, LLC
HyperBand
2016-11-18
GE Medical Systems, LLC
Optima XR240amx
2016-11-15
GE Medical Systems, LLC
MAGiC
2016-08-31
GE Medical Systems, LLC
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
2016-06-09
GE MEDICAL SYSTEMS, LLC
Low Dose CT Lung Cancer Screening Option For Qualified GE Systems
2015-08-14
GE Medical Systems, LLC
Customer Remote Console (CRC)
2015-03-24
GE MEDICAL SYSTEMS, LLC
Discovery MR750 3.0T
2014-12-05
GE MEDICAL SYSTEMS, LLC
SIGNA PET/MR
2014-11-24
GE MEDICAL SYSTEMS, LLC
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
2014-09-26
GE MEDICAL SYSTEMS, LLC
Optima XR200amx, Optima XR220amx
2014-09-25
GE Medical Systems, LLC
DISCOVERY IQ
2014-09-18
GE MEDICAL SYSTEMS, LLC
CORTEX ID SUITE
2014-09-18
GE MEDICAL SYSTEMS, LLC
REVOLUTION CT
2014-04-11
GE MEDICAL SYSTEMS, LLC
ASIR-V
2014-03-25
GE MEDICAL SYSTEMS, LLC
DISCOVERY PET/CT 710
2014-03-21
GE MEDICAL SYSTEMS, LLC
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
2014-01-17
GE MEDICAL SYSTEMS, LLC
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
2013-11-18
GE MEDICAL SYSTEMS, LLC

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