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
| Country | Makers |
|---|---|
| United States | 9 |
| India | 5 |
| China | 4 |
| Germany | 2 |
| Japan | 2 |
| Netherlands | 2 |
| Mexico | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ge Medical Systems, LLC | Waukesha, WI, United States | Specification developer | 1 | August 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Contract manufacturer, Manufacturer | 1 | April 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Brainspec, Inc | Framingham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | KASHIWA-SHI Chiba, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | 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 (tianjin) Company Limited | Tianjin, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Coils | Aurora, OH, United States | Manufacturer, 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 | |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | 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 | |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Medical, Inc | Wilmington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Global Business Services LLP | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips India Limited - Magnetic Resonance Business Unit | Bengaluru Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Electrodynamics | Mayfield Village, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rapid Biomedical GMBH | RIMPAR Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Shenzhen Magnetic Resonance Ltd. | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Pvt. Ltd. | Bangalore, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Healthcare Private Ltd | WHITEFIELD, BANGALORE Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.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.