Data / Medical devices / System, Nuclear Magnetic Resonance Imaging
System, Nuclear Magnetic Resonance Imaging (LNH): 103 FDA-registered makers in 18 countries
103 establishments in 18 countries are registered with the FDA to make System, Nuclear Magnetic Resonance Imaging (product code LNH, Class 2, 21 CFR 892.1000). 79 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 1,110 510(k) clearances under this code, the latest on October 9, 2026, and lists 189 recall events (6 Class I). FDA data exported November 2, 2026.
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- Product code
- LNH
- Device class
- 2
- Regulation
- 892.1000
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 49 |
| China | 11 |
| India | 7 |
| Germany | 6 |
| Japan | 5 |
| Netherlands | 3 |
| Denmark | 3 |
| Sweden | 3 |
| Italy | 2 |
| Mexico | 2 |
| United Kingdom | 2 |
| Canada | 2 |
| South Korea | 2 |
| Israel | 2 |
| France | 1 |
| Australia | 1 |
| Norway | 1 |
| Brazil | 1 |
Makers of System, Nuclear Magnetic Resonance Imaging
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Complaint file establishment, Contract manufacturer, Manufacturer | 82 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer, Specification developer | 59 | August 13, 2026 | 0 | 11 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 49 | March 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 49 | March 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Shenzhen Magnetic Resonance Ltd. | SHENZHEN Guangdong, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 49 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 38 | August 13, 2026 | 0 | 1 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 37 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare (tianjin) Company Limited | Tianjin, China | Manufacturer, Specification developer | 36 | August 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 30 | August 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Magnetic Resonance Business Unit | Bengaluru Karnataka, India | Specification developer | 26 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Coils | Aurora, OH, United States | Manufacturer, Specification developer | 20 | February 6, 2026 | 0 | 3 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 18 | February 5, 2026 | 0 | 1 | 0 | api.fda.gov |
| Wipro Ge Healthcare Private Ltd | WHITEFIELD, BANGALORE Karnataka, India | Manufacturer | 17 | February 4, 2015 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | KASHIWA-SHI Chiba, Japan | Manufacturer | 13 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | Manufacturer | 13 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Scandinavian Medical Solutions A/S | Aalborg Nordjylland, Denmark | Exporter to the US, Manufacturer | 13 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| GE HEALTHCARE (CHINA) CO., LTD. - Tianjin | Tianjin, China | Specification developer | 12 | February 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 12 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Esaote S.P.A. | GENOVA Liguria, Italy | Manufacturer | 11 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Complaint file establishment, Manufacturer | 9 | August 6, 2025 | 0 | 4 | 1 | api.fda.gov |
| Syntheticmr AB | Linkoping Ostergotland, Sweden | Manufacturer | 8 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 7 | November 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Perspectum Ltd. | Oxford Oxfordshire, United Kingdom | Manufacturer | 6 | March 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems SCS | Buc, France | Manufacturer | 5 | August 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| MRI DIVISION, Beijing Wandong Medical Technology Co.,Ltd | Beijing, China | Manufacturer | 5 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Philips Global Business Services LLP | Pune Maharashtra, India | Manufacturer | 5 | March 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| DXTX Medical Inc. | Pittsburgh, PA, United States | Complaint file establishment, Manufacturer | 4 | July 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Quality Electrodynamics | Mayfield Village, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | February 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Anholt Technologies Inc. | Avondale, PA, United States | Manufacturer | 3 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Fonar Corp. | Melville, NY, United States | Manufacturer | 3 | January 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Ivy Biomedical Systems, Inc. | Branford, CT, United States | Manufacturer | 3 | March 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medtec LLC | Orange City, IA, United States | Manufacturer | 3 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 3 | March 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Resonance Health Analysis Services Pty Ltd | Burswood Western Australia, Australia | Manufacturer | 3 | June 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| ASG Superconductors S.p.A. | Genova, Italy | Manufacturer | 2 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medical Outfitters, Inc | Miami, FL, United States | Repackager or relabeler, Reprocessor | 2 | September 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Mriaudio, Inc. | Carlsbad, CA, United States | Manufacturer | 2 | January 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Myocardial Solutions | Durham, NC, United States | Manufacturer | 2 | August 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Neocoil, LLC | Pewaukee, WI, United States | Manufacturer | 2 | February 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| NORAS MRI products GMBH | HOECHBERG Bavaria, Germany | Contract manufacturer, Manufacturer | 2 | November 8, 2005 | 0 | 0 | 0 | api.fda.gov |
| Nordicneurolab AS | BERGEN Hordaland, Norway | Manufacturer | 2 | March 20, 2026 | 0 | 2 | 0 | api.fda.gov |
| Springbok Analytics | Charlottesville, VA, United States | Complaint file establishment, Manufacturer | 2 | September 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Synaptive Medical Inc | Mississauga Ontario, Canada | Manufacturer | 2 | October 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| TracInnovations A/S | Ballerup Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 2 | August 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xingaoyi Medical Equipment Co., Ltd | Yuyao Zhejiang, China | Manufacturer | 2 | August 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| AIRS Medical Inc. | Seoul, South Korea | Complaint file establishment, Manufacturer | 1 | October 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Amra Medical AB | Linkoping Ostergotland, Sweden | Manufacturer | 1 | November 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aspect Imaging Ltd | Shoham Tel Aviv, Israel | Manufacturer | 1 | July 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Avotec, Inc. | Stuart, FL, United States | Manufacturer | 1 | May 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Manufacturer | 1 | May 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Elekta Solutions AB | Stockholm, Sweden | Exporter to the US, Specification developer | 1 | June 6, 2001 | 0 | 0 | 0 | api.fda.gov |
| Ge Healthcare | Chicago, IL, United States | Specification developer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Heuron Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | July 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hyperfine, Inc | Guilford, CT, United States | Manufacturer | 1 | December 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Magspin Instrument Co., Ltd | Kunshan Jiangsu, China | Exporter to the US, Manufacturer | 1 | December 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Neoscan Solutions GMBH | Magdeburg Saxony-Anhalt, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 1 | July 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Northh Medical GMBH | Hamburg, Germany | Manufacturer, Specification developer | 1 | February 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nova Medical, Inc | Wilmington, MA, United States | Contract manufacturer, Manufacturer | 1 | October 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Optoacoustics Ltd. | Mazor Central, Israel | Manufacturer | 1 | May 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer, Exporter to the US | 1 | July 10, 2020 | 0 | 5 | 0 | api.fda.gov |
| PRENUVO Inc. | Redwood City, CA, United States | Manufacturer | 1 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Prism Clinical Imaging, Inc. | Elm Grove, WI, United States | Manufacturer | 1 | September 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Promaxo, LLC | Oakland, CA, United States | Specification developer | 1 | March 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Philips DS North America LLC | Gainesville, FL, United States | Complaint file establishment, Specification developer | 1 | October 11, 2002 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems (Cleveland), Inc. | Gainesville, FL, United States | Complaint file establishment, Specification developer | 1 | June 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Rapid Biomedical GMBH | RIMPAR Bavaria, Germany | Manufacturer | 1 | February 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Resonance Technology, Inc. | Northridge, CA, United States | Manufacturer | 1 | March 22, 2000 | 0 | 1 | 0 | api.fda.gov |
| Resoundant, Inc. | Rochester, MN, United States | Manufacturer, Specification developer | 1 | July 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 1 | March 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Sino Canada Health Engineering Research Institute (hefei) Ltd. (scheri) | Hefei Anhui, China | Complaint file establishment, Manufacturer | 1 | March 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Spintech, Inc. | Bingham Farms, MI, United States | Manufacturer | 1 | October 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sun Nuclear Corporation | Melbourne, FL, United States | Manufacturer | 1 | June 6, 2001 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen RF Tech Co., Ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 1 | March 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Turing Medical Technologies, Inc. | Saint Louis, MO, United States | Manufacturer | 1 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vassol, Inc. | River Forest, IL, United States | Manufacturer | 1 | February 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Vista AI Inc. | Redwood City, CA, United States | Manufacturer | 1 | June 25, 2014 | 0 | 0 | 0 | api.fda.gov |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 1 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Nashua, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brainreader | Aalborg Nordjylland, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CIVCO Medical Instruments Co., Inc. | Coralville, IA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation - Bremen | Bremen, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diacor, Inc. | Mount Pleasant, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elekta Limited | CRAWLEY West Sussex, United Kingdom | 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 Medical Systems, LLC | Waukesha, WI, United States | Manufacturer, Specification developer | 0 | 0 | 43 | 1 | api.fda.gov | |
| GEXPRO, a Division of REXEL USA, Inc. | Menomonee Falls, WI, United States | Contract 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 | |
| Ionic Health Technologies SA | Sao Jose dos Campos Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kluge Design Inc. | Rogers, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSync Corporation | Coral Springs, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Macromedics BV | Moordrecht Zuid-Holland, Netherlands | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnettx Oncology Solutions Ltd | Edmonton Alberta, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Chenguang Medical Technologies Co, Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Pvt. Ltd. | Bangalore, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Subtle Medical Inc | Menlo Park, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecma Operaciones S. De R.L. De C.V. | Juarez Chihuahua, Mexico | 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 | |
| Viewray Systems, Inc. | Oakwood Village, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziosoft, Inc. | Minato-ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 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.