Data / Medical devices / United States / Ge Medical Systems, LLC

Ge Medical Systems, LLC: FDA-registered device maker in Waukesha, WI, United States, 73 510(k) clearances

Name: Ge Medical Systems, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ge Medical Systems, LLC is registered with the FDA (registration 2183553) in Waukesha, WI, United States. It lists 9 device types. The FDA files 73 510(k) clearances under its listings, the newest dated August 13, 2026. 12 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Ge Medical Systems, LLC

FDA registration number: 2183553
Address: 3200 N Grandview BLVD, Waukesha, WI, United States, 53188
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer, Specification developer
First device listed: August 17, 1998
Registered through: 2027
Brand names listed: 1.5T Detachable Table, 1.5T GE 6-Channel Phased Array Flex Coil, 1.5T GE Signa Excite HD MR System, 1.5T GEM Anterior Array, 1.5T GEM HNU, 1.5T GEM PA, 1.5T GEM PVA, 1.5T INFINITY TWINSPEED MR SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Specification developer	accessdata.fda.gov
Radiological Image Processing Software For Radiation Therapy	QKB	2	Specification developer	accessdata.fda.gov
Synchronizer, Ecg / Respirator, Radiographic	IXO	1	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Specification developer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Specification developer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Specification developer	accessdata.fda.gov
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	OUO	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 13, 2026	K253808	AIR Recon DL	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
February 6, 2026	K253780	SIGNA Bolt	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
December 23, 2025	K252379	AIR Recon DL	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 5, 2025	K243667	Sonic DL	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
May 30, 2023	K223523	Sonic DL	LNH	Substantially Equivalent	Ge Medical Systems,Llc (Ge Healthcare)	accessdata.fda.gov
August 25, 2022	K211841	MRI Planner	MUJ	Substantially Equivalent	Spectronic Medical AB	accessdata.fda.gov
June 8, 2022	K213717	AIR Recon DL	LNH	Substantially Equivalent	Ge Medical Systems,Llc (Ge Healthcare)	accessdata.fda.gov
January 20, 2022	K213709	SIGNA PET/MR	OUO	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 20, 2022	K213668	SIGNA Hero	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
May 13, 2021	K211118	SIGNA 7.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 13, 2020	K202966	SIGNA Architect	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
October 15, 2020	K201615	SIGNA 7.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 10, 2020	K193282	SIGNA Premier	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
January 18, 2019	K183231	SIGNA Premier	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 14, 2017	K171128	SIGNA Premier	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 20, 2017	K162722	HyperSense	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 17, 2017	K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
February 14, 2017	K163619	SIGNA PET/MR	OUO	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 18, 2016	K162403	HyperBand	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 31, 2016	K161397	MAGiC	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 9, 2016	K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 29, 2016	K160621	SIGNAPioneer	LNH	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 27, 2015	K153003	SIGNA Pioneer	LNH	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
July 10, 2015	K143345	SIGNA Pioneer	LNH	Substantially Equivalent	Ge Healthcare Japan Corporation	accessdata.fda.gov
December 5, 2014	K142361	Discovery MR750 3.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 24, 2014	K142098	SIGNA PET/MR	OUO	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 26, 2014	K142085	DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 15, 2013	K132376	DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
May 23, 2013	K130115	DISCOVERY MR750W 3.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 13, 2013	K123522	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
January 18, 2013	K121762	CARDIAC VX	LLZ	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
December 11, 2012	K113394	MAVRIC SL	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 13, 2012	K123068	OPTIMA MR 430S	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 20, 2012	K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 13, 2012	K113490	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 30, 2011	K103327	DISCOVERY MR750W 3.0T	LNH	Substantially Equivalent	Ge Healthcare Japan Corporation	accessdata.fda.gov
April 1, 2011	K110610	1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL	MOS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
March 22, 2011	K103411	IDEAL IQ SOFTWARE OPTION	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
March 7, 2011	K103335	GEM OPTION FOR 1.5 MRI SYSTEMS	MOS	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
February 11, 2011	K103238	1.5T OPTIMA MR430S	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
August 31, 2010	K102155	MR RADIATION ONCOLOGY OPTIONS	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 6, 2010	K092925	3D ASL	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 24, 2009	K083421	MR-TOUCH OPTION	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 17, 2009	K091536	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 4, 2008	K083147	DISCOVERY MR450	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 22, 2008	K081916	GE SIGNA MR ONCOLOGY PACKAGE	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 25, 2008	K081028	SIGNA 3.0T MR750 SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
February 6, 2008	K080048	MSK EXTREME MR SCANNER, MODEL AA5000	LNH	Substantially Equivalent	Oni Medical Systems, Inc.	accessdata.fda.gov
January 4, 2008	K073167	BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 1, 2007	K072998	IDEAL SOFTWARE OPTION FOR GE MR SCANNERS	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 21, 2005	K052293	GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 12, 2005	K043262	GE SIGNA EXCITE MR SURGICAL OPTION	LNH	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
November 3, 2004	K042844	GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL	MOS	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
June 17, 2004	K041476	GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 14, 2004	K040444	GE SIGNA 3.0T WITH EXCITE MR SYSTEM	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
December 19, 2003	K033867	GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
July 2, 2003	K031927	GE DELTA SOFTWARE OPTION FOR MRI	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
May 13, 2003	K031396	ADVANTAGE WORKSTATION PASTING 1.1	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
April 10, 2003	K030953	GE 3.0T GENERAL PURPOSE FLEX COIL	MOS	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
March 28, 2003	K030874	GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
January 24, 2002	K013636	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
August 22, 2001	K011604	PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI	LNI	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
August 3, 2001	K012200	1.5T INFINITY TWINSPEED MR SYSTEM	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
April 3, 2001	K003613	3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL	MOS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
January 23, 2001	K003573	DIFFUSION TENSOR IMAGING OPTION	LNH	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
August 18, 2000	K001773	ORTHONE	LNH	Substantially Equivalent	Oni, Inc.	accessdata.fda.gov
June 30, 1998	K981190	HIGH IMPEDANCE CARDIAC GATING CABLE	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
July 23, 1997	K971667	CARDIAC PHASED ARRAY COIL	MOS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
November 27, 1996	K962061	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
July 3, 1996	K960265	ADVANTAGE WINDOWS WITH FUNCTOOL OPTION	LLZ	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
October 27, 1995	K953595	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	MOS	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
September 30, 1992	K923264	GENERAL PURPOSE FLEX COIL	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
June 28, 1991	K911806	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 20, 2025	97187	Class II	Ongoing	GE Signa Artist, Nuclear Magnetic Resonance Imaging System	GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only),	accessdata.fda.gov
May 23, 2025	97030	Class II	Ongoing	SIGNA Architect	GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection wi	accessdata.fda.gov
October 28, 2024	95735	Class II	Ongoing	Discovery MR750w 3.0T, whole body magnetic resonance scanner	Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.	accessdata.fda.gov
June 14, 2024	94874	Class II	Ongoing	SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System	GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in	accessdata.fda.gov
October 3, 2018	81348	Class II	Terminated	SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use a	A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.	accessdata.fda.gov
June 7, 2018	80323	Class II	Terminated	GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T	The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.	accessdata.fda.gov
June 6, 2018	80264	Class II	Terminated	Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 54	GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.	accessdata.fda.gov
March 30, 2018	80287	Class II	Terminated	MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance	There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.	accessdata.fda.gov
May 11, 2017	77488	Class II	Terminated	Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.	accessdata.fda.gov
December 7, 2015	72892	Class II	Terminated	GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.	GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall	accessdata.fda.gov
December 21, 2006	37848	Not yet classified	Terminated	Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI	When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.	accessdata.fda.gov
June 1, 2006	37653	Not yet classified	Terminated	GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System	To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.	accessdata.fda.gov

Compare with other makers

Updated August 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.