Data / Medical devices / Coil, Magnetic Resonance, Specialty
Coil, Magnetic Resonance, Specialty (MOS): 47 FDA-registered makers in 8 countries
47 establishments in 8 countries are registered with the FDA to make Coil, Magnetic Resonance, Specialty (product code MOS, Class 2, 21 CFR 892.1000). 31 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 491 510(k) clearances under this code, the latest on October 5, 2026, and lists 17 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MOS
- Device class
- 2
- Regulation
- 892.1000
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 25 |
| China | 8 |
| Germany | 4 |
| Japan | 4 |
| India | 3 |
| Netherlands | 1 |
| Mexico | 1 |
| Israel | 1 |
Makers of Coil, Magnetic Resonance, Specialty
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Exporter to the US, Specification developer | 89 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips Global Business Services LLP | Pune Maharashtra, India | Manufacturer | 57 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Coils | Aurora, OH, United States | Manufacturer, Specification developer | 42 | January 23, 2026 | 0 | 1 | 0 | api.fda.gov |
| Quality Electrodynamics | Mayfield Village, OH, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer | 33 | February 28, 2025 | 0 | 3 | 0 | api.fda.gov |
| Neocoil, LLC | Pewaukee, WI, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 17 | April 23, 2026 | 0 | 2 | 0 | api.fda.gov |
| NORAS MRI products GMBH | HOECHBERG Bavaria, Germany | Contract manufacturer, Manufacturer | 14 | June 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen RF Tech Co., Ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 11 | April 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 11 | June 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Specification developer | 7 | April 1, 2011 | 0 | 1 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 6 | August 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 6 | August 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Inkspace Imaging, Inc | Pleasanton, CA, United States | Manufacturer | 6 | October 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| DXTX Medical Inc. | Pittsburgh, PA, United States | Complaint file establishment, Manufacturer | 5 | July 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Rapid Biomedical GMBH | RIMPAR Bavaria, Germany | Manufacturer | 5 | February 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Chenguang Medical Technologies Co, Ltd | Shanghai, China | Exporter to the US, Manufacturer | 5 | July 28, 2010 | 0 | 0 | 0 | api.fda.gov |
| Wipro Ge Healthcare Private Ltd | WHITEFIELD, BANGALORE Karnataka, India | Manufacturer | 5 | February 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Manufacturer | 4 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | KASHIWA-SHI Chiba, Japan | Manufacturer | 3 | February 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | Manufacturer | 3 | February 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Polarean, Inc. | Durham, NC, United States | Complaint file establishment, Specification developer | 3 | November 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Shenzhen Magnetic Resonance Ltd. | SHENZHEN Guangdong, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 3 | January 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 2 | September 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare (tianjin) Company Limited | Tianjin, China | Manufacturer, Specification developer | 2 | February 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| LMT Medical Systems GMBH | Lubeck Schleswig-Holstein, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 2 | July 26, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medspira LLC | Minneapolis, MN, United States | Manufacturer | 2 | April 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| Monteris Medical Corp | Minnetonka, MN, United States | Complaint file establishment, Manufacturer | 2 | January 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 1 | October 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | March 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Complaint file establishment, Manufacturer | 1 | February 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Nova Medical, Inc | Wilmington, MA, United States | Contract manufacturer, Manufacturer | 1 | April 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Scanmed, LLC | Omaha, NE, United States | Manufacturer | 1 | December 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Aspect Imaging Ltd | Shoham Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avnet, Inc. (Avnet Logistics) | Chandler, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Nashua, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation - Bremen | Bremen, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evolve Manufacturing Technologies Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE HEALTHCARE (CHINA) CO., LTD. - Tianjin | Tianjin, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HM Product Solutions, Ltd. | Hartland, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hyperfine, Inc | Guilford, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promaxo, LLC | Oakland, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Usa (limited) LLC | Lakeland, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Pvt. Ltd. | Bangalore, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uih Technologies, LLC | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 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.