GE Healthcare (China) Co., Ltd.
Registered establishment in Beijing, China. 22 device types.
GE Healthcare (China) Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Table, Radiologic, System, X-Ray, Mobile and 20 other device types. Its earliest product listing with the FDA dates from 1978.
22device types registered with the FDA
24recalls
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008284470 |
| FEI number | 3008284470 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | 1F-5F BLD 1, No.1 Tongji South Road |
| Postal code | 100176 |
| Country | China |
Group
GE Healthcare (China) Co., Ltd. is one of 5 plants registered under GE HealthCare Technologies Inc..
| Plant | City | Device types |
|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | 22 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | 57 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | 3 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | Class 1 | LU45645STR, Solarix 350 Brightspeed, LU8548ST, Performix Pro VCT 100, Performix Plus, Performix VCT Plus and 40 more | 1999 | 13 |
| Automated Radiological Image Processing Software | Class 2 | OEC One CFD | 2025 | 8 |
| Coil, Magnetic Resonance, Specialty | Class 2 | TDI Head Neck Array, SIGNA Pioneer, TDI Posterior Array, 3T AA, GE 8CH Foot Ankle Coil, SIGNA Sprint Select and 10 more | 2012 | 9 |
| Collimator, Automatic, Radiographic | Class 2 | LU50090, HELIOS Collimator, X-Ray Collimator, OEC Beam Limiting Device, Prodigy/DPX Series Collimator Assembly, Lunar iDXA series Collimator Assembly and 1 more | 2014 | 5 |
| Holder, Radiographic Cassette, Wall-Mounted | Class 1 | Wallstand (GCMWS-C5), WALL MOUNTED CASSETTE HOLDER Wallstand for X-Ray System, Wallstand (Model: VMWS-1; VMWS-2), Wallstand (Model: GCEWS-C4), Wallstand (Model: GCWS-C3; GCWS-C5; GCWS-C6) | 1978 | 6 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Class 2 | OEC One CFD, OEC Brivo 865 Plus, OEC Brivo Prime, Brivo OEC 715, OEC Brivo Essential, Brivo OEC 865 and 22 more | 2013 | 3 |
| Instrument, Quality-Assurance, Radiologic | Class 1 | IQST assembly, Quality Care Suite 2 | 2009 | 3 |
| Interventional Fluoroscopic X-Ray System | Class 2 | OEC One CFD, OEC One, Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5 and 27 more | 2013 | 5 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | Definium Tempo Select, Definium Pace Select, Optima XR646, Definium 5000, Discovery XR650, Definium 8000 and 12 more | 2010 | 13 |
| Support, Patient Position | Class 1 | Repressing Belt-Rohs, REPRESSING BELT-Standard table, Repression Belt (B2100BLT), Compression Band (Model: 5794807) | 2018 | 66 |
| System, Nuclear Magnetic Resonance Imaging | Class 2 | TDI Head Neck Array, SIGNA Pioneer, TDI Posterior Array, 3T AA, SIGNA Victor, SIGNA Sprint Select and 23 more | 2007 | 12 |
| System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | SIGNA Sprint Select, SIGNA Prime Elite, SIGNA Artist Evo, SIGNA Hero, SIGNA Champion, SIGNA Sprint and 2 more | 2020 | 4 |
| System, X-Ray, Angiographic | Class 2 | Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5, IGS WF SP, 3DXR and 24 more | 2013 | 7 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Class 2 | OEC One CFD, OEC Brivo 865 Plus, OEC Brivo Prime, Brivo OEC 715, OEC Brivo Essential, Brivo OEC 865 and 37 more | 2013 | 9 |
| System, X-Ray, Mobile | Class 2 | Collimator X-Ray, Collimator, Optima XR220amx, Brivo XR285amx, Optima XR200amx | 2011 | 5 |
| System, X-Ray, Stationary | Class 2 | Definium Tempo Select, Definium Pace Select, Optima XR646, Brivo XR385, Definium 5000, Discovery XR650 and 12 more | 2007 | 7 |
| System, X-Ray, Tomographic | Class 2 | Discovery XR650, Definium 8000, Discovery XR656, Optima XR640, Discovery XR656 HD with VolumeRad, Definium Tempo Pro and 6 more | 2010 | 2 |
| System, X-Ray, Tomography, Computed | Class 2 | LightSpeed Pro32, LightSpeed VCT, LightSpeed VCT Select, Discovery RT, Optima CT580 W, Optima CT580 RT and 58 more | 2010 | 8 |
| Table, Radiographic, Non-Tilting, Powered | Class 2 | GCTBL-C4, Lite (LITE TABLE N9 ED3, Lite Table), VT1700 (GT1700 N9 ED3), VT2000 (GT2000 N9 ED3), GT1700V(GT1700V N9 ED3, GT1700V), VT1700V(GT1700V N9 ED3) and 18 more | 2004 | 3 |
| Table, Radiographic, Tilting | Class 2 | Table (Model: GCTBL-C44) | 2002 | 2 |
| Table, Radiologic | Class 2 | 3T Detachable Table, 1.5T Detachable Table, 3T eXpress Table, 1.5T eXpress Table | 1998 | 4 |
| Tube Mount, X-Ray, Diagnostic | Class 1 | OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8), Tubestand (Model: GCTS-C11), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10), OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1) and 3 more | 1978 | 5 |
Clearances
No clearance names GE Healthcare (China) Co., Ltd. as applicant. 60 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253779 | 2026-02-05 | LNH | Traditional | GE Medical Systems, LLC |
| K253269 | 2025-11-26 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K251399 | 2025-09-11 | LNH | Traditional | GE Medical Systems, LLC |
| K250788 | 2025-08-28 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K250941 | 2025-08-01 | JAK | Traditional | GE Medical Systems, LLC |
| K250379 | 2025-03-17 | LNH | Traditional | GE Medical Systems, LLC |
| K240828 | 2024-12-27 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K242678 | 2024-10-01 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K233749 | 2024-02-22 | JAK | Special | GE Hangwei Medical Systems Co., Ltd. |
| K233728 | 2024-01-19 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K231892 | 2023-09-12 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K223439 | 2023-02-13 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K213603 | 2022-02-11 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K213668 | 2022-01-20 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K211980 | 2022-01-16 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K213715 | 2021-12-17 | JAK | Special | GE Medical Systems, LLC |
| K203617 | 2021-03-02 | JAK | Traditional | GE Medical Systems, LLC |
| K202238 | 2020-09-04 | LNH | Special | GE Healthcare (Tianjin) Company Limited |
| K192956 | 2020-01-16 | JAK | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K192686 | 2019-10-24 | JAK | Special | GE Hangwei Medical Systems Co., Ltd. |
| K192426 | 2019-10-01 | LNH | Special | GE Healthcare (Tianjin) Company Limited |
| K191699 | 2019-07-24 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K182626 | 2018-11-16 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K181403 | 2018-11-02 | OWB | Traditional | GE Healthcare GmbH |
| K173612 | 2017-12-11 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K172700 | 2017-11-09 | OWB | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K172869 | 2017-10-20 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K171800 | 2017-07-12 | OXO | Special | Ge Hualun Medical Systems Co., Ltd. |
| K171013 | 2017-06-05 | JAK | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K161567 | 2016-09-01 | LNH | Traditional | GE Healthcare GmbH |
| K160131 | 2016-06-21 | OXO | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K160621 | 2016-03-29 | LNH | Special | GE Healthcare GmbH |
| K153429 | 2016-03-09 | JAK | Traditional | Ge Hangwei Medical System Co., Ltd. |
| K153003 | 2015-10-27 | LNH | Special | GE Healthcare GmbH |
| K143345 | 2015-07-10 | LNH | Traditional | GE Healthcare Japan Corporation |
| K143270 | 2015-02-18 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K143251 | 2015-02-04 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K132410 | 2014-01-17 | JAK | Traditional | GE Medical Systems, LLC |
| K132261 | 2013-11-18 | IZF | Traditional | GE Medical Systems, LLC |
| K131576 | 2013-08-30 | JAK | Traditional | GE Medical Systems, LLC |
| K123603 | 2013-05-17 | OXO | Traditional | Ge Healthcare Surgery GE Oec Medical Systems, Inc. |
| K123596 | 2013-02-08 | JAK | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K122457 | 2013-01-02 | OWB | Traditional | GE Healthcare GmbH |
| K122694 | 2012-10-25 | MOS | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K120833 | 2012-06-12 | JAK | Special | GE Medical Systems, LLC |
| K103448 | 2011-08-12 | KPR | Traditional | GE Medical Systems, LLC |
| K110227 | 2011-07-20 | JAK | Special | GE Medical Systems, LLC |
| K103476 | 2011-06-16 | IZL | Traditional | GE Medical Systems, LLC |
| K093581 | 2011-04-19 | JAK | Traditional | GE Medical Systems, LLC |
| K102615 | 2010-11-18 | MQB | Traditional | GE Medical Systems, LLC |
| K082816 | 2008-10-08 | JAK | Traditional | GE Medical Systems, LLC |
| K082761 | 2008-10-08 | JAK | Traditional | GE Medical Systems, LLC |
| K063283 | 2006-11-17 | MQB | Special | Sedecal., Sa. |
| K061817 | 2006-07-12 | JAK | Traditional | GE Medical Systems, LLC |
| K052978 | 2005-11-09 | LNH | Special | GE Medical Systems, LLC |
| K051967 | 2005-08-09 | KPR | Traditional | GE Healthcare GmbH |
| K040372 | 2004-03-01 | JAK | Traditional | GE Medical Systems, LLC |
| K992746 | 1999-11-09 | LNH | Traditional | GE Medical Systems, LLC |
| K993090 | 1999-10-01 | KPR | Traditional | GE Medical Systems, LLC |
| K913673 | 1992-01-23 | LNH | Traditional | General Electric Co. |
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 241 |
| 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 188 |
| 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 2538 |
| 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 33 |
| 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 22 |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 5 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 2 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 10 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 8 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 4 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 4 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 4 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 11 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 1 unit |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 5 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 11 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 3 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 3 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 72 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 10 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 3 units |
| 2024-11-05 | Class II | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if app | 16 units |
| 2024-10-24 | Class II | Equipment maintenance | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. | 956 systems |
| 2024-07-12 | Class II | Error in labeling | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injur | 3572 units |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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