Data / Medical devices / United States / GE Healthcare Manufacturing LLC
GE Healthcare Manufacturing LLC: FDA-registered device maker in Florence, SC, United States, 41 510(k) clearances
GE Healthcare Manufacturing LLC is registered with the FDA (registration 3005326970) in Florence, SC, United States. It lists 4 device types. The FDA files 41 510(k) clearances under its listings, the newest dated August 13, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005326970
- Address
- 3001 W Radio DR, Florence, SC, United States, 29501
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer
- First device listed
- August 23, 2005
- Registered through
- 2027
- Brand names listed
- 1.5T AIR Posterior Array, 1.5T Anterior Array, 1.5T GE Signa Excite HD MR System, 1.5T SIGNA HDXt, 1.5T SPLIT HEAD COIL, 1.5T Signa HD, 1.5T Signa HDxt Mobile, 1.5T TDI Head Neck Array and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Manufacturer | 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 |
| 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 |
| May 13, 2021 | K211118 | SIGNA 7.0T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 13, 2020 | K202966 | SIGNA Architect | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| October 15, 2020 | K201615 | SIGNA 7.0T | LNH | 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 |
| 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 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | LNH | Substantially Equivalent | Ge Medical Systems, LLC | 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 |
| August 31, 2010 | K102155 | MR RADIATION ONCOLOGY OPTIONS | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 17, 2009 | K091536 | OPTIMA MR450W | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 22, 2008 | K081916 | GE SIGNA MR ONCOLOGY PACKAGE | LNH | 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 |
| September 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 12, 2005 | K043262 | GE SIGNA EXCITE MR SURGICAL OPTION | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 17, 2004 | K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 27, 2026 | 98579 | Class II | Ongoing | SIGNA Premier systems | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings po | 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 Coil, Magnetic Resonance, Specialty
- All makers of Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
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.