Data / Medical devices / China / Ge Healthcare (tianjin) Company Limited
Ge Healthcare (tianjin) Company Limited: FDA-registered device maker in Tianjin, China, 41 510(k) clearances
Ge Healthcare (tianjin) Company Limited is registered with the FDA (registration 3010949642) in Tianjin, China. It lists 5 device types. The FDA files 41 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010949642
- Address
- No. 266 Jingsan Road Tianjin Airport Economic Area, Tianjin, China, 300308
- 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 4CH Large Flex Coil, 1.5T 4CH Small Flex Coil, 1.5T AIR Posterior Array, 1.5T Anterior Array, 1.5T Detachable Table, 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY, 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY, 1.5T Split Head Coil and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer, 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 | Manufacturer, 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 | Manufacturer | 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 |
| February 5, 2026 | K253779 | SIGNA Sprint Select | 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 |
| September 11, 2025 | K251399 | SIGNA Sprint | 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 |
| March 17, 2025 | K250379 | SIGNA Prime Elite | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 19, 2024 | K233728 | SIGNA Champion | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| May 30, 2023 | K223523 | Sonic DL | LNH | Substantially Equivalent | Ge Medical Systems,Llc (Ge Healthcare) | accessdata.fda.gov |
| February 13, 2023 | K223439 | SIGNA Victor | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| June 8, 2022 | K213717 | AIR Recon DL | LNH | Substantially Equivalent | Ge Medical Systems,Llc (Ge Healthcare) | accessdata.fda.gov |
| February 11, 2022 | K213603 | SIGNA Artist Evo | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | 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 |
| January 16, 2022 | K211980 | SIGNA Prime | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| November 13, 2020 | K202966 | SIGNA Architect | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| September 4, 2020 | K202238 | SIGNA Artist | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| April 10, 2020 | K193282 | SIGNA Premier | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| October 1, 2019 | K192426 | Signa Voyager, Signa Voyager Quantum | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | 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 |
| 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 |
| September 1, 2016 | K161567 | SIGNA Voyager | LNH | Substantially Equivalent | GE Healthcare | 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 |
| February 4, 2015 | K143251 | SIGNA Creator, SIGNA Explorer | LNH | Substantially Equivalent | Ge Healthcare (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 |
| February 22, 2013 | K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL | MOS | Substantially Equivalent | Wipro GE Healthcare Private, Ltd. | accessdata.fda.gov |
| January 17, 2013 | K123417 | BRIVO MR355, OPTIMA MR360 | LNH | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| October 25, 2012 | K122694 | GE 8CH FOOT ANKLE COIL | MOS | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | 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 |
| February 11, 2011 | K103330 | BRIVO MR355, OPTIMA MR360 | LNH | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| July 17, 2009 | K091536 | OPTIMA MR450W | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of Table, Radiologic
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.