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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.

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.

Product code
LNH
Device class
2
Regulation
892.1000
Medical specialty
Radiology

Makers by country

CountryMakers
United States49
China11
India7
Germany6
Japan5
Netherlands3
Denmark3
Sweden3
Italy2
Mexico2
United Kingdom2
Canada2
South Korea2
Israel2
France1
Australia1
Norway1
Brazil1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthineers AGERLANGEN Bavaria, GermanyComplaint file establishment, Contract manufacturer, Manufacturer82September 1, 2026000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer59August 13, 20260110api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanManufacturer49March 27, 2026000api.fda.gov
Canon Inc.OHTA-KU Tokyo, JapanSpecification developer49March 27, 2026000api.fda.gov
Siemens Shenzhen Magnetic Resonance Ltd.SHENZHEN Guangdong, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer49September 1, 2026000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer38August 13, 2026010api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsComplaint file establishment, Specification developer37February 23, 2026000api.fda.gov
Ge Healthcare (tianjin) Company LimitedTianjin, ChinaManufacturer, Specification developer36August 13, 2026000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer30August 13, 2026000api.fda.gov
Philips India Limited - Magnetic Resonance Business UnitBengaluru Karnataka, IndiaSpecification developer26February 23, 2026000api.fda.gov
GE Healthcare CoilsAurora, OH, United StatesManufacturer, Specification developer20February 6, 2026030api.fda.gov
GE Healthcare (China) Co., Ltd.Beijing, ChinaSpecification developer18February 5, 2026010api.fda.gov
Wipro Ge Healthcare Private LtdWHITEFIELD, BANGALORE Karnataka, IndiaManufacturer17February 4, 2015000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KashiwaKASHIWA-SHI Chiba, JapanManufacturer13September 16, 2026000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Kashiwa OfficeKashiwa-shi Chiba, JapanManufacturer13September 16, 2026000api.fda.gov
Scandinavian Medical Solutions A/SAalborg Nordjylland, DenmarkExporter to the US, Manufacturer13December 19, 2025000api.fda.gov
GE HEALTHCARE (CHINA) CO., LTD. - TianjinTianjin, ChinaSpecification developer12February 5, 2026000api.fda.gov
Shanghai United Imaging Healthcare Co.,ltd.Shanghai, ChinaManufacturer12September 25, 2025000api.fda.gov
Esaote S.P.A.GENOVA Liguria, ItalyManufacturer11July 31, 2026000api.fda.gov
IMRIS Imaging, Inc.Chaska, MN, United StatesComplaint file establishment, Manufacturer9August 6, 2025041api.fda.gov
Syntheticmr ABLinkoping Ostergotland, SwedenManufacturer8December 6, 2024000api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.APODACA Nuevo Leon, MexicoManufacturer7November 13, 2020000api.fda.gov
Perspectum Ltd.Oxford Oxfordshire, United KingdomManufacturer6March 9, 2026000api.fda.gov
Ge Medical Systems SCSBuc, FranceManufacturer5August 31, 2016000api.fda.gov
MRI DIVISION, Beijing Wandong Medical Technology Co.,LtdBeijing, ChinaManufacturer5July 1, 2022000api.fda.gov
Philips Global Business Services LLPPune Maharashtra, IndiaManufacturer5March 22, 2011000api.fda.gov
DXTX Medical Inc.Pittsburgh, PA, United StatesComplaint file establishment, Manufacturer4July 3, 1997000api.fda.gov
Quality ElectrodynamicsMayfield Village, OH, United StatesComplaint file establishment, Manufacturer, Specification developer4February 12, 2025000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer3June 8, 2012000api.fda.gov
Fonar Corp.Melville, NY, United StatesManufacturer3January 18, 2001000api.fda.gov
Ivy Biomedical Systems, Inc.Branford, CT, United StatesManufacturer3March 2, 2021000api.fda.gov
Medtec LLCOrange City, IA, United StatesManufacturer3June 8, 2012000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer3March 16, 2010000api.fda.gov
Resonance Health Analysis Services Pty LtdBurswood Western Australia, AustraliaManufacturer3June 20, 2023000api.fda.gov
ASG Superconductors S.p.A.Genova, ItalyManufacturer2November 26, 2024000api.fda.gov
Medical Outfitters, IncMiami, FL, United StatesRepackager or relabeler, Reprocessor2September 21, 2005000api.fda.gov
Mriaudio, Inc.Carlsbad, CA, United StatesManufacturer2January 6, 2020000api.fda.gov
Myocardial SolutionsDurham, NC, United StatesManufacturer2August 26, 2024000api.fda.gov
Neocoil, LLCPewaukee, WI, United StatesManufacturer2February 16, 2018000api.fda.gov
NORAS MRI products GMBHHOECHBERG Bavaria, GermanyContract manufacturer, Manufacturer2November 8, 2005000api.fda.gov
Nordicneurolab ASBERGEN Hordaland, NorwayManufacturer2March 20, 2026020api.fda.gov
Springbok AnalyticsCharlottesville, VA, United StatesComplaint file establishment, Manufacturer2September 9, 2025000api.fda.gov
Synaptive Medical IncMississauga Ontario, CanadaManufacturer2October 11, 2023000api.fda.gov
TracInnovations A/SBallerup Hovedstaden, DenmarkComplaint file establishment, Manufacturer2August 29, 2022000api.fda.gov
Xingaoyi Medical Equipment Co., LtdYuyao Zhejiang, ChinaManufacturer2August 17, 2026000api.fda.gov
AIRS Medical Inc.Seoul, South KoreaComplaint file establishment, Manufacturer1October 1, 2026000api.fda.gov
Amra Medical ABLinkoping Ostergotland, SwedenManufacturer1November 24, 2021000api.fda.gov
Aspect Imaging LtdShoham Tel Aviv, IsraelManufacturer1July 19, 2017000api.fda.gov
Avotec, Inc.Stuart, FL, United StatesManufacturer1May 13, 1993000api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesManufacturer1May 4, 1998000api.fda.gov
Elekta Solutions ABStockholm, SwedenExporter to the US, Specification developer1June 6, 2001000api.fda.gov
Ge HealthcareChicago, IL, United StatesSpecification developer1October 27, 2023000api.fda.gov
Heuron Co., Ltd.Seoul, South KoreaManufacturer1July 12, 2022000api.fda.gov
Hyperfine, IncGuilford, CT, United StatesManufacturer1December 12, 2025000api.fda.gov
Jiangsu Magspin Instrument Co., LtdKunshan Jiangsu, ChinaExporter to the US, Manufacturer1December 22, 2015000api.fda.gov
Neoscan Solutions GMBHMagdeburg Saxony-Anhalt, GermanyComplaint file establishment, Exporter to the US, Manufacturer1July 22, 2024000api.fda.gov
Northh Medical GMBHHamburg, GermanyManufacturer, Specification developer1February 4, 2022000api.fda.gov
Nova Medical, IncWilmington, MA, United StatesContract manufacturer, Manufacturer1October 15, 2020000api.fda.gov
Optoacoustics Ltd.Mazor Central, IsraelManufacturer1May 24, 2012000api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsContract manufacturer, Exporter to the US1July 10, 2020050api.fda.gov
PRENUVO Inc.Redwood City, CA, United StatesManufacturer1January 17, 2025000api.fda.gov
Prism Clinical Imaging, Inc.Elm Grove, WI, United StatesManufacturer1September 21, 2012000api.fda.gov
Promaxo, LLCOakland, CA, United StatesSpecification developer1March 3, 2021000api.fda.gov
Philips DS North America LLCGainesville, FL, United StatesComplaint file establishment, Specification developer1October 11, 2002000api.fda.gov
Philips Medical Systems (Cleveland), Inc.Gainesville, FL, United StatesComplaint file establishment, Specification developer1June 25, 2004000api.fda.gov
Rapid Biomedical GMBHRIMPAR Bavaria, GermanyManufacturer1February 15, 2019000api.fda.gov
Resonance Technology, Inc.Northridge, CA, United StatesManufacturer1March 22, 2000010api.fda.gov
Resoundant, Inc.Rochester, MN, United StatesManufacturer, Specification developer1July 10, 2020000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer1March 17, 2017000api.fda.gov
Sino Canada Health Engineering Research Institute (hefei) Ltd. (scheri)Hefei Anhui, ChinaComplaint file establishment, Manufacturer1March 20, 2023000api.fda.gov
Spintech, Inc.Bingham Farms, MI, United StatesManufacturer1October 28, 2022000api.fda.gov
Sun Nuclear CorporationMelbourne, FL, United StatesManufacturer1June 6, 2001000api.fda.gov
Shenzhen RF Tech Co., Ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer1March 2, 2023000api.fda.gov
Turing Medical Technologies, Inc.Saint Louis, MO, United StatesManufacturer1August 26, 2020000api.fda.gov
Vassol, Inc.River Forest, IL, United StatesManufacturer1February 5, 2002000api.fda.gov
Vista AI Inc.Redwood City, CA, United StatesManufacturer1June 25, 2014000api.fda.gov
WIPRO GE HEALTHCARE PRIVATE Ltd.BANGALORE Karnataka, IndiaSpecification developer1October 27, 2023000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer1March 17, 2025000api.fda.gov
Wipro GE Healthcare Private Ltd.Bangalore Karnataka, IndiaManufacturer1October 27, 2023000api.fda.gov
Benchmark Electronics, Inc.Nashua, NH, United StatesContract manufacturer0000api.fda.gov
BrainreaderAalborg Nordjylland, DenmarkSpecification developer0000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer0000api.fda.gov
Creative Foam Corporation - BremenBremen, IN, United StatesContract manufacturer0000api.fda.gov
Diacor, Inc.Mount Pleasant, UT, United StatesManufacturer0000api.fda.gov
Elekta LimitedCRAWLEY West Sussex, United KingdomContract manufacturer0000api.fda.gov
Evolve Manufacturing Technologies Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer00431api.fda.gov
GEXPRO, a Division of REXEL USA, Inc.Menomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Ionic Health Technologies SASao Jose dos Campos Sao Paulo, BrazilManufacturer0000api.fda.gov
Kluge Design Inc.Rogers, MN, United StatesContract manufacturer0000api.fda.gov
LifeSync CorporationCoral Springs, FL, United StatesContract manufacturer0000api.fda.gov
Macromedics BVMoordrecht Zuid-Holland, NetherlandsManufacturer, Repackager or relabeler0000api.fda.gov
Magnettx Oncology Solutions LtdEdmonton Alberta, CanadaManufacturer0000api.fda.gov
Multisource Manufacturing LLCLongmont, CO, United StatesContract manufacturer0000api.fda.gov
Shanghai Chenguang Medical Technologies Co, LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Siemens Healthcare Pvt. Ltd.Bangalore, IndiaContract manufacturer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Subtle Medical IncMenlo Park, CA, United StatesManufacturer0000api.fda.gov
Tecma Operaciones S. De R.L. De C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Uih Technologies, LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Viewray Systems, Inc.Oakwood Village, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ziosoft, Inc.Minato-ku Tokyo, JapanManufacturer0000api.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.