Data / Medical devices / System, Nuclear Magnetic Resonance Imaging / United States
FDA-registered makers of System, Nuclear Magnetic Resonance Imaging in the United States: 49 establishments
49 establishments in the United States are registered with the FDA to make System, Nuclear Magnetic Resonance Imaging (product code LNH). 35 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Nuclear Magnetic Resonance Imaging
- Product code
- LNH
- Country
- United States
Makers of System, Nuclear Magnetic Resonance Imaging in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer, Specification developer | 59 | August 13, 2026 | 0 | 11 | 0 | api.fda.gov |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 38 | August 13, 2026 | 0 | 1 | 0 | api.fda.gov |
| GE Healthcare Manufacturing LLC | Florence, SC, United States | Manufacturer | 30 | August 13, 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 |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Complaint file establishment, Manufacturer | 9 | August 6, 2025 | 0 | 4 | 1 | 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 |
| 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 |
| Springbok Analytics | Charlottesville, VA, United States | Complaint file establishment, Manufacturer | 2 | September 9, 2025 | 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 |
| Ge Healthcare | Chicago, IL, United States | Specification developer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hyperfine, Inc | Guilford, CT, United States | Manufacturer | 1 | December 12, 2025 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Benchmark Electronics, Inc. | Nashua, NH, United States | Contract manufacturer | 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 | |
| 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 | |
| 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 | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Subtle Medical Inc | Menlo Park, CA, United States | 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 |
Updated November 2, 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.