Data / Medical devices / China / GE Healthcare (China) Co., Ltd.
GE Healthcare (China) Co., Ltd.: FDA-registered device maker in Beijing, China, 60 510(k) clearances
GE Healthcare (China) Co., Ltd. is registered with the FDA (registration 3008284470) in Beijing, China. It lists 22 device types. The FDA files 60 510(k) clearances under its listings, the newest dated February 5, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008284470
- Address
- 1F-5F BLD 1, No.1 Tongji South Road Beijing Economic-Technological Development Area, Beijing, China, 100176
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- 1.5T AIR Posterior Array, 1.5T Anterior Array, 1.5T Detachable Table, 1.5T SPLIT HEAD COIL, 1.5T TDI Head Neck Array, 1.5T TDI Posterior Array, 1.5T eXpress Table, 3DXR and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| February 5, 2026 | K253779 | SIGNA Sprint Select | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 26, 2025 | K253269 | OEC One CFD | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| September 11, 2025 | K251399 | SIGNA Sprint | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 28, 2025 | K250788 | Definium Tempo Select | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| August 1, 2025 | K250941 | Revolution Vibe | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 17, 2025 | K250379 | SIGNA Prime Elite | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 27, 2024 | K240828 | OEC One ASD | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| October 1, 2024 | K242678 | Definium Pace Select ET | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| February 22, 2024 | K233749 | Revolution Ascend Sliding | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 19, 2024 | K233728 | SIGNA Champion | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| September 12, 2023 | K231892 | Definium Pace Select | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| February 13, 2023 | K223439 | SIGNA Victor | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| February 11, 2022 | K213603 | SIGNA Artist Evo | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| January 20, 2022 | K213668 | SIGNA Hero | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| January 16, 2022 | K211980 | SIGNA Prime | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| December 17, 2021 | 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 | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 2, 2021 | K203617 | MaxFOV 2 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 4, 2020 | K202238 | SIGNA Artist | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| January 16, 2020 | K192956 | Auto Positioning | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| October 24, 2019 | K192686 | Revolution Maxima, Revolution Ace | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| October 1, 2019 | K192426 | Signa Voyager, Signa Voyager Quantum | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| July 24, 2019 | K191699 | Discovery XR656 HD with VolumeRad | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| November 16, 2018 | K182626 | OEC One | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| November 2, 2018 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 11, 2017 | K173612 | Optima XR646 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| November 9, 2017 | K172700 | OEC One | OWB | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| October 20, 2017 | K172869 | Discovery XR656 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| July 12, 2017 | K171800 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| June 5, 2017 | K171013 | Revolution ACT | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| September 1, 2016 | K161567 | SIGNA Voyager | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 21, 2016 | K160131 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| March 29, 2016 | K160621 | SIGNAPioneer | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 9, 2016 | K153429 | SmartView 3D Option | JAK | Substantially Equivalent | Ge Hangwei Medical System Co., Ltd. | 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 |
| February 18, 2015 | K143270 | Optima XR646 | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| February 4, 2015 | K143251 | SIGNA Creator, SIGNA Explorer | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| January 17, 2014 | K132410 | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2013 | K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | IZF | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 17, 2013 | K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| February 8, 2013 | K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 25, 2012 | K122694 | GE 8CH FOOT ANKLE COIL | MOS | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 12, 2011 | K103448 | BRIVO XR385 | KPR | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 16, 2011 | K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2010 | K102615 | WIRELESS DR IMAGING OPTION-WDR1 | MQB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 17, 2006 | K063283 | DEFINIUM 5000 X-RAY SYSTEM | MQB | Substantially Equivalent | Sedecal., Sa. | accessdata.fda.gov |
| July 12, 2006 | K061817 | LIGHTSPEED 7.1 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 9, 2005 | K052978 | GE 1.5T SIGNA HDE MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 9, 2005 | K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | KPR | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 1, 2004 | K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 9, 1999 | K992746 | SIGNA HFO/I MAGNETIC RESONANCE SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| October 1, 1999 | K993090 | SILHOUETTE FC | KPR | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| January 23, 1992 | K913673 | VECTRA MAGNETIC RESONANCE SYSTEM | 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 |
|---|---|---|---|---|---|---|
| January 31, 2025 | 96311 | Class II | Ongoing | SIGNA Creator, SIGNA Explorer, NMRI systems | 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 intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient i | accessdata.fda.gov |
| November 5, 2024 | 95704 | Class II | Ongoing | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: | 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 applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The | accessdata.fda.gov |
| October 24, 2024 | 95674 | Class II | Ongoing | GE Proteus XR/A radiographic system | 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. | accessdata.fda.gov |
| July 12, 2024 | 95222 | Class II | Ongoing | GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Availab | 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 injury during de-install. | accessdata.fda.gov |
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Updated February 5, 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.