GE Healthcare (Tianjin) Company Limited
Manufacturer and brand owner in Tianjin, China. 5 device types, 4 products catalogued, 6 clearances.
GE Healthcare (Tianjin) Company Limited is a specification developer holding a current FDA establishment registration. The registration covers Table, Radiologic, Coil, Magnetic Resonance, Specialty and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 1998.
5device types registered with the FDA
4products catalogued under its own name
6510(k) clearances
Registration
| Registered name | GE HEALTHCARE (TIANJIN) COMPANY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010949642 |
| FEI number | 3010949642 |
| DUNS | 421356265 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 通用电气医疗系统（天津）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 266 Jingsan Road |
| Postal code | 300308 |
| Country | China |
Group
GE Healthcare (Tianjin) Company Limited is one of 5 plants registered under GE HealthCare Technologies Inc..
| Plant | City | Device types |
|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | 22 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | 57 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | 3 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | Class 2 | 1.5T 4CH Large Flex Coil, 1.5T 4CH Small Flex Coil, 1.5T TDI Head Neck Array, SIGNA Voyager Quantum, 1.5T TDI Posterior Array, Signa Voyager Premier Edition and 23 more | 2011 | 9 |
| System, Nuclear Magnetic Resonance Imaging | Class 2 | Discovery MR750 3T, Optima MR450w 1.5T, Discovery MR450 1.5T, Discovery MR750w 3T, Discovery MR450, Optima MR450w and 54 more | 2010 | 12 |
| System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | 8ch Express Suite, Brivo MR355, Optima MR360, Express Coil – Anterior Array, Express Coil – Posterior Array, Express Coil – Head Neck Array and 18 more | 2011 | 4 |
| Table, Radiologic | Class 2 | 3T Detachable Table, 1.5T Detachable Table, 3T eXpress Table, 1.5T eXpress Table | 1998 | 4 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | Class 2 | 3T LAA, 3T PET/MR CMA, Signa PET/MR, 3T UAA, 3T HNU | 2014 | 3 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 16 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 6 |
| Coil, Magnetic Resonance, Specialty | MOS | 5 |
| Table, Radiologic | KXJ | 4 |
Clearances
6 clearances name GE Healthcare (Tianjin) Company Limited as applicant. 34 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 |
|---|---|---|---|---|
| K233728 | 2024-01-19 | LNH | Traditional | This company |
| K223439 | 2023-02-13 | LNH | Traditional | This company |
| K213603 | 2022-02-11 | LNH | Traditional | This company |
| K211980 | 2022-01-16 | LNH | Traditional | This company |
| K202238 | 2020-09-04 | LNH | Special | This company |
| K192426 | 2019-10-01 | LNH | Special | This company |
| K253780 | 2026-02-06 | LNH | Traditional | GE Medical Systems, LLC |
| K253779 | 2026-02-05 | LNH | Traditional | GE Medical Systems, LLC |
| K252379 | 2025-12-23 | LNH | Traditional | GE Medical Systems, LLC |
| K251399 | 2025-09-11 | LNH | Traditional | GE Medical Systems, LLC |
| K243667 | 2025-06-05 | LNH | Traditional | GE Medical Systems, LLC |
| K250379 | 2025-03-17 | LNH | Traditional | GE Medical Systems, LLC |
| K223523 | 2023-05-30 | LNH | Traditional | Ge Medical Systems,Llc (Ge Healthcare) |
| K213717 | 2022-06-08 | LNH | Traditional | Ge Medical Systems,Llc (Ge Healthcare) |
| K213668 | 2022-01-20 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K213709 | 2022-01-20 | OUO | Traditional | GE Medical Systems, LLC |
| K202966 | 2020-11-13 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K193282 | 2020-04-10 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K183231 | 2019-01-18 | LNH | Traditional | GE Medical Systems, LLC |
| K171128 | 2017-07-14 | LNH | Traditional | GE Medical Systems, LLC |
| K163331 | 2017-03-17 | LNH | Traditional | GE Medical Systems, LLC |
| K163619 | 2017-02-14 | OUO | Traditional | GE Medical Systems, LLC |
| K161567 | 2016-09-01 | LNH | Traditional | GE Healthcare GmbH |
| K160618 | 2016-06-09 | LNH | Special | GE Medical Systems, LLC |
| K160621 | 2016-03-29 | LNH | Special | GE Healthcare GmbH |
| K153003 | 2015-10-27 | LNH | Special | GE Healthcare GmbH |
| K143345 | 2015-07-10 | LNH | Traditional | GE Healthcare Japan Corporation |
| K143251 | 2015-02-04 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K142098 | 2014-11-24 | OUO | Traditional | GE Medical Systems, LLC |
| K142085 | 2014-09-26 | LNH | Traditional | GE Medical Systems, LLC |
| K132376 | 2013-11-15 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K130115 | 2013-05-23 | LNH | Traditional | GE Medical Systems, LLC |
| K123522 | 2013-03-13 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K123681 | 2013-02-22 | MOS | Traditional | Wipro GE Healthcare Private Ltd. |
| K123417 | 2013-01-17 | LNH | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K122694 | 2012-10-25 | MOS | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K113490 | 2012-01-13 | LNH | Traditional | GE Medical Systems, LLC |
| K103327 | 2011-09-30 | LNH | Traditional | GE Healthcare Japan Corporation |
| K103330 | 2011-02-11 | LNH | Traditional | GE Hangwei Medical Systems Co., Ltd. |
| K091536 | 2009-07-17 | LNH | Traditional | GE Medical Systems, LLC |
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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