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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

CountryMakers
United States25
China8
Germany4
Japan4
India3
Netherlands1
Mexico1
Israel1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsComplaint file establishment, Exporter to the US, Specification developer89July 30, 2026000api.fda.gov
Philips Global Business Services LLPPune Maharashtra, IndiaManufacturer57July 30, 2026000api.fda.gov
GE Healthcare CoilsAurora, OH, United StatesManufacturer, Specification developer42January 23, 2026010api.fda.gov
Quality ElectrodynamicsMayfield Village, OH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer33February 28, 2025030api.fda.gov
Neocoil, LLCPewaukee, WI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer17April 23, 2026020api.fda.gov
NORAS MRI products GMBHHOECHBERG Bavaria, GermanyContract manufacturer, Manufacturer14June 7, 2024000api.fda.gov
Shenzhen RF Tech Co., Ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer11April 14, 2026000api.fda.gov
Siemens Healthineers AGERLANGEN Bavaria, GermanyComplaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer11June 24, 2009000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesSpecification developer7April 1, 2011010api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanManufacturer6August 17, 2012000api.fda.gov
Canon Inc.OHTA-KU Tokyo, JapanSpecification developer6August 17, 2012000api.fda.gov
Inkspace Imaging, IncPleasanton, CA, United StatesManufacturer6October 5, 2026000api.fda.gov
DXTX Medical Inc.Pittsburgh, PA, United StatesComplaint file establishment, Manufacturer5July 17, 2025000api.fda.gov
Rapid Biomedical GMBHRIMPAR Bavaria, GermanyManufacturer5February 1, 2023000api.fda.gov
Shanghai Chenguang Medical Technologies Co, LtdShanghai, ChinaExporter to the US, Manufacturer5July 28, 2010000api.fda.gov
Wipro Ge Healthcare Private LtdWHITEFIELD, BANGALORE Karnataka, IndiaManufacturer5February 22, 2013000api.fda.gov
Philips Healthcare (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaComplaint file establishment, Manufacturer4March 20, 2026000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KashiwaKASHIWA-SHI Chiba, JapanManufacturer3February 11, 2008000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Kashiwa OfficeKashiwa-shi Chiba, JapanManufacturer3February 11, 2008000api.fda.gov
Polarean, Inc.Durham, NC, United StatesComplaint file establishment, Specification developer3November 19, 2024000api.fda.gov
Siemens Shenzhen Magnetic Resonance Ltd.SHENZHEN Guangdong, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer3January 11, 2011000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer2September 8, 2011000api.fda.gov
Ge Healthcare (tianjin) Company LimitedTianjin, ChinaManufacturer, Specification developer2February 22, 2013000api.fda.gov
LMT Medical Systems GMBHLubeck Schleswig-Holstein, GermanyComplaint file establishment, Exporter to the US, Manufacturer2July 26, 2017000api.fda.gov
Medspira LLCMinneapolis, MN, United StatesManufacturer2April 14, 2004000api.fda.gov
Monteris Medical CorpMinnetonka, MN, United StatesComplaint file establishment, Manufacturer2January 27, 2014000api.fda.gov
GE Healthcare (China) Co., Ltd.Beijing, ChinaSpecification developer1October 25, 2012000api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.APODACA Nuevo Leon, MexicoManufacturer1March 7, 2011000api.fda.gov
IMRIS Imaging, Inc.Chaska, MN, United StatesComplaint file establishment, Manufacturer1February 2, 2011000api.fda.gov
Nova Medical, IncWilmington, MA, United StatesContract manufacturer, Manufacturer1April 12, 2019000api.fda.gov
Scanmed, LLCOmaha, NE, United StatesManufacturer1December 5, 2014000api.fda.gov
Aspect Imaging LtdShoham Tel Aviv, IsraelManufacturer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Nashua, NH, United StatesContract manufacturer0000api.fda.gov
Creative Foam Corporation - BremenBremen, IN, United StatesContract manufacturer0000api.fda.gov
Evolve Manufacturing Technologies Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
GE HEALTHCARE (CHINA) CO., LTD. - TianjinTianjin, ChinaSpecification developer0000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer0000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer0000api.fda.gov
Hyperfine, IncGuilford, CT, United StatesManufacturer0000api.fda.gov
Promaxo, LLCOakland, CA, United StatesSpecification developer0000api.fda.gov
Shanghai United Imaging Healthcare Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Siemens Healthcare Pvt. Ltd.Bangalore, IndiaContract manufacturer0000api.fda.gov
Uih Technologies, LLCHouston, TX, United StatesContract manufacturer0000api.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.