GE HEALTHCARE (TIANJIN) COMPANY LIMITED

FDA Device Registration & Listing · Tianjin, CN · Registration 3010949642

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010949642
FEI Number
3010949642
Entity Name
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
City/State/Country
Tianjin, CN
Establishment Address
No. 266 Jingsan Road, Tianjin Airport Economic Area, Tianjin 300308, CN
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

AIR Recon DL 1.5T 4CH Large Flex Coil 1.5T 4CH Small Flex Coil Optima MR450w 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table SIGNA Bolt 3T AIR PA XL Discovery MR450 Optima MR450w 1.5T Discovery MR750 3T SIGNA Architect Discovery MR450 1.5T SIGNA Artist Discovery MR750w 3T Optima MR450w 1.5T Discovery MR450 1.5T Discovery MR750 3T SIGNA Artist Discovery MR750w 3T SIGNA Architect Sonic DL SIGNA Premier SIGNA Artist Evo SIGNA Premier SIGNA PET/MR SIGNA Champion Optima MR450w SIGNA Sprint Select SIGNA Prime Elite SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA SIGNA PET/MR SIGNA Premier 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) AIR Recon DL SIGNA Architect GE 8CH Foot Ankle Coil SIGNA Prime SIGNA Hero 3T HNU 3T LAA 3T PET/MR CMA 3T UAA SIGNA PET/MR 9E Express AA coil 16CH Express HNA coil 8ch Express PA coil 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY Discovery MR450 1.5T Optima MR450w 1.5T Discovery MR750w 3T Discovery MR750 3T Discovery MR450 Discovery MR750w 3T 3T AA TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer Sonic DL SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w

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 2022-11-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-03-05
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-03-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-03-20
KXJ Table, Radiologic Radiology Class 2 892.1980 1998-08-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2026-03-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-03-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-03-09
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 2017-04-13
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-06-02
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
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-03-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-03-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-03-07
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
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2017-02-14
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
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2010-07-15
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
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-04-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-04-03
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 2017-01-04
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2017-01-04
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2023-05-16
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 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 2026-01-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-12-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2012-11-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-01-17
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
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2014-12-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-02-05
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-11-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-05-31
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-05-31
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2013-05-31
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-02-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-02-22
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-06-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2015-02-11
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2012-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

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 3010949642. Last updated year: 2026. Please use registration number 3010949642 when referencing this establishment in official correspondence.
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