Data / Medical devices / China / GE HEALTHCARE (CHINA) CO., LTD. - Tianjin
GE HEALTHCARE (CHINA) CO., LTD. - Tianjin: FDA-registered device maker in Tianjin, China, 12 510(k) clearances
GE HEALTHCARE (CHINA) CO., LTD. - Tianjin is registered with the FDA (registration 3013343065) in Tianjin, China. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 5, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013343065
- Address
- No. 1, inside No. 266 Jing San Road Tianjin Airport Economic Zone, Tianjin, China, 300308
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- February 11, 2015
- Registered through
- 2027
- Brand names listed
- 1.5T AIR Posterior Array, 1.5T Anterior Array, 1.5T TDI Head Neck Array, 1.5T TDI Posterior Array, 3T AA, SIGNA Artist, SIGNA Artist Evo, SIGNA Champion and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 5, 2026 | K253779 | SIGNA Sprint Select | 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 |
| 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 |
| 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 |
| September 4, 2020 | K202238 | SIGNA Artist | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| October 1, 2019 | K192426 | Signa Voyager, Signa Voyager Quantum | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| March 29, 2016 | K160621 | SIGNAPioneer | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 4, 2015 | K143251 | SIGNA Creator, SIGNA Explorer | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
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.