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Data / Medical devices / System, Nuclear Magnetic Resonance Spectroscopic

System, Nuclear Magnetic Resonance Spectroscopic (LNI): 25 FDA-registered makers in 7 countries

25 establishments in 7 countries are registered with the FDA to make System, Nuclear Magnetic Resonance Spectroscopic (product code LNI, Class 2, 21 CFR 892.1000). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on March 16, 2010, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LNI
Device class
2
Regulation
892.1000
Medical specialty
Radiology

Makers by country

CountryMakers
United States9
India5
China4
Germany2
Japan2
Netherlands2
Mexico1

Makers of System, Nuclear Magnetic Resonance Spectroscopic

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
Ge Medical Systems, LLCWaukesha, WI, United StatesSpecification developer1August 22, 2001000api.fda.gov
Siemens Healthineers AGERLANGEN Bavaria, GermanyContract manufacturer, Manufacturer1April 3, 1997000api.fda.gov
Brainspec, IncFramingham, MA, United StatesManufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KashiwaKASHIWA-SHI Chiba, JapanManufacturer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Kashiwa OfficeKashiwa-shi Chiba, JapanManufacturer0000api.fda.gov
GE HEALTHCARE (CHINA) CO., LTD. - TianjinTianjin, ChinaSpecification developer0000api.fda.gov
Ge Healthcare (tianjin) Company LimitedTianjin, ChinaManufacturer, Specification developer0000api.fda.gov
GE Healthcare (China) Co., Ltd.Beijing, ChinaSpecification developer0000api.fda.gov
GE Healthcare CoilsAurora, OH, United StatesManufacturer, Specification developer0000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer0000api.fda.gov
GE Healthcare Manufacturing LLCFlorence, SC, United StatesManufacturer0000api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
IMRIS Imaging, Inc.Chaska, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nova Medical, IncWilmington, MA, United StatesManufacturer0000api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsContract manufacturer0000api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsComplaint file establishment, Specification developer0000api.fda.gov
Philips Global Business Services LLPPune Maharashtra, IndiaManufacturer0000api.fda.gov
Philips India Limited - Magnetic Resonance Business UnitBengaluru Karnataka, IndiaSpecification developer0000api.fda.gov
Quality ElectrodynamicsMayfield Village, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Rapid Biomedical GMBHRIMPAR Bavaria, GermanyManufacturer0000api.fda.gov
Siemens Shenzhen Magnetic Resonance Ltd.SHENZHEN Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Siemens Healthcare Pvt. Ltd.Bangalore, IndiaContract manufacturer0000api.fda.gov
Wipro Ge Healthcare Private LtdWHITEFIELD, BANGALORE Karnataka, IndiaManufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov

Updated March 16, 2010. 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.