Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015329423

FEI Number

3015329423

Entity Name

GE Healthcare Manufacturing LLC

City/State/Country

Florence, SC, US

Establishment Address

3280 General Williams W. Dr., Florence, SC 29506, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233728

PMA Number

N/A

All Registered Proprietary Names

SIGNA Premier Sonic DL SIGNA Artist SIGNA Premier AIR Recon DL SIGNA Architect 3T SIGNA HDxt Mobile 3T SPLIT HEAD COIL 1.5T SPLIT HEAD COIL SIGNA VIBRANT 3T SIGNA HDXt 1.5T SIGNA HDXt 1.5T Signa HDxt Mobile SIGNA Premier SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD Sonic DL SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 SIGNA PET/MR SIGNA PET/MR SIGNA Sprint 1.5T AIR Posterior Array Discovery MR450 Optima MR450w 1.5T Discovery MR750 3T SIGNA Architect Discovery MR450 1.5T SIGNA Artist Discovery MR750w 3T Signa HDi 1.5T 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL GE 3T Signa HDxt MR System Signa HDi GE 1.5T Signa HDx MR System GE 1.5T Signa HDxt MR System GE 3T Signa HDx MR System Signa Vibrant AIR Recon DL Discovery MR750w 3T Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) SIGNA Sprint Select Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w 3T HNU 3T LAA 3T PET/MR CMA 3T UAA SIGNA PET/MR SIGNA Hero SIGNA Champion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-07-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-07-22
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-07-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-06-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-09-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-09-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-09-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-05-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-05-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-05-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-11-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-12-02
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2012-11-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-11-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-11-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-08-11
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2017-08-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-08-11
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-09-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-09-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2005-08-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-06-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-02-11
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2017-02-14
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2023-05-16
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-09-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-09-18
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-09-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-07-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2007-11-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-01-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-11-03
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2011-11-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-11-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-02-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-02-09
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-02-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-01-16
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	Class 2	892.1200	2014-12-02
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-01-26
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-01-26
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2024-01-25
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015329423. Last updated year: 2026. Please use registration number 3015329423 when referencing this establishment in official correspondence.