Data / Medical devices / United States / GE Healthcare Coils
GE Healthcare Coils: FDA-registered device maker in Aurora, OH, United States, 64 510(k) clearances
GE Healthcare Coils is registered with the FDA (registration 1529041) in Aurora, OH, United States. It lists 6 device types. The FDA files 64 510(k) clearances under its listings, the newest dated February 6, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1529041
- FEI number
- 3005214683
- Address
- 1515 Danner DR, Aurora, OH, United States, 44202
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 7, 2003
- Registered through
- 2027
- Brand names listed
- 1.5T 12 Ch Body Array DV Single, 1.5T 12 Ch Body Array HDx Dual, 1.5T 12 Ch Body Array HDx Single, 1.5T 16-Ch Peripheral Vascular Coil, 1.5T 16ch AIR AA, 1.5T 16ch AIR Anterior Array, 1.5T 30ch AIR AA, 1.5T 30ch AIR Anterior Array and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cradle, Patient, Radiologic | KXH | 1 | 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 |
| Test-Pattern, Radiographic | IXF | 1 | 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 |
|---|---|---|---|---|---|---|
| February 6, 2026 | K253780 | SIGNA Bolt | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 23, 2026 | K253738 | 3.0T AIR 32CH HNA | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| September 11, 2025 | K251399 | SIGNA Sprint | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 3, 2023 | K223378 | 3.0T 16ch AIR AA | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| October 1, 2019 | K192426 | Signa Voyager, Signa Voyager Quantum | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| October 19, 2018 | K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA | MOS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 12, 2018 | K182504 | 3.0T Air MP M, 3.0T Air MP L | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| April 12, 2018 | K180666 | 48CH Head Coil | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| November 22, 2017 | K172695 | AIR Anterior Array, AIR Posterior Array | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| January 12, 2017 | K163205 | 48CH Head Coil | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| September 1, 2016 | K161567 | SIGNA Voyager | LNH | Substantially Equivalent | GE Healthcare | 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 |
| March 6, 2015 | K143389 | 3.0T GEM RT Open Array | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| November 24, 2014 | K142098 | SIGNA PET/MR | OUO | Substantially Equivalent | 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 |
| January 11, 2013 | K123327 | 1.5T GEM RT OPEN ARRAY | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| November 16, 2012 | K122174 | PEDIATRIC POSITIONER PAD SET | KXH | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | 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 |
| September 30, 2011 | K103327 | DISCOVERY MR750W 3.0T | LNH | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| March 7, 2011 | K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS | MOS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 11, 2011 | K103330 | BRIVO MR355, OPTIMA MR360 | LNH | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 12, 2011 | K103365 | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| June 23, 2010 | K101492 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| November 25, 2009 | K093348 | 3.0T 16 CHANNEL HEAD NECK SPINE COIL | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| November 4, 2008 | K083147 | DISCOVERY MR450 | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 25, 2008 | K081028 | SIGNA 3.0T MR750 SYSTEM | 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 |
| October 7, 2005 | K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| October 7, 2005 | K052584 | 1.5T 12 CHANNEL BODY ARRAY | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| October 4, 2005 | K052585 | 3T HD BREAST ARRAY | MOS | Substantially Equivalent | Usa Instruments, Inc. | 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 |
| September 24, 2004 | K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| August 26, 2004 | K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| August 11, 2004 | K042009 | MARK III PHASED ARRAY SHOULDER COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| July 23, 2004 | K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | LNH | Substantially Equivalent | Usa Instruments, Inc. | 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 |
| September 12, 2003 | K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| August 25, 2003 | K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| July 30, 2003 | K032045 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | MOS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| July 11, 2003 | K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| May 29, 2003 | K031172 | SPIRIT III TOTALSENSE CARDIAC COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| May 29, 2003 | K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| May 23, 2003 | K031209 | GE 1.5T 8 CHANNEL TORSO COIL | MOS | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| May 5, 2003 | K030371 | PRIMA III TOTALSENSE TORSO COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| April 10, 2003 | K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL | MOS | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| March 5, 2003 | K030495 | 3.0T TORSO PHASED ARRAY COIL | MOS | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| June 27, 2002 | K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| January 24, 2002 | K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY | LNH | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| May 30, 2001 | K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| August 14, 2000 | K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| July 17, 2000 | K001582 | LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| April 14, 2000 | K000437 | INTERVENTIONAL BODY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| February 23, 2000 | K000002 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| February 14, 2000 | K994345 | MAGNA 5000 PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| January 18, 2000 | K994040 | PHASED ARRAY KNEE AND FOOT COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| November 16, 1998 | K983143 | MARK 5000 PHASED ARRAY SHOULDER COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| April 13, 1998 | K980157 | PREMIER 7000 CTL SPINE COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| August 21, 1997 | K972340 | INSIGHT 7000 PHASED ARRAY TORSO COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| July 23, 1997 | K971667 | CARDIAC PHASED ARRAY COIL | MOS | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 30, 1992 | K923264 | GENERAL PURPOSE FLEX COIL | LNH | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| June 28, 1991 | K911806 | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY | 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, 2007 | 37263 | Not yet classified | Terminated | The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, | The packaging used for the Breast Biopsy plate may exhibit small holes or tears | accessdata.fda.gov |
| November 21, 2006 | 36866 | Not yet classified | Terminated | LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 | The packaging used for the Breast Biopsy Plate may exhibit small holes or tears. | accessdata.fda.gov |
| September 20, 2006 | 36612 | Not yet classified | Terminated | 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. | The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used. | accessdata.fda.gov |
| March 19, 2004 | 28693 | Not yet classified | Terminated | Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions. | A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body. | accessdata.fda.gov |
Compare with other makers
- All makers of Coil, Magnetic Resonance, Specialty
- 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 Cradle, Patient, Radiologic
- All makers of Test-Pattern, Radiographic
Updated February 6, 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.