Data / Medical devices / System, Radiation Therapy, Charged-Particle, Medical / United States
FDA-registered makers of System, Radiation Therapy, Charged-Particle, Medical in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make System, Radiation Therapy, Charged-Particle, Medical (product code LHN). 10 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Radiation Therapy, Charged-Particle, Medical
- Product code
- LHN
- Country
- United States
Makers of System, Radiation Therapy, Charged-Particle, Medical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mevion Medical Systems, Inc. | Littleton, MA, United States | Manufacturer | 4 | March 25, 2026 | 0 | 10 | 0 | api.fda.gov |
| Ehmet Health | Plymouth, MI, United States | Manufacturer | 1 | December 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Empnia Inc. | Eden Prairie, MN, United States | Manufacturer | 1 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intraop Medical Corp. | Fremont, CA, United States | Manufacturer | 1 | July 24, 1998 | 0 | 1 | 0 | api.fda.gov |
| Massachusetts General Hospital | Boston, MA, United States | Manufacturer | 1 | September 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| McLaren Health Care | Flint, MI, United States | Manufacturer | 1 | February 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Optivus Proton Therapy, Inc. | San Bernardino, CA, United States | Manufacturer | 1 | July 21, 2000 | 0 | 0 | 0 | api.fda.gov |
| Pronova Solutions, LLC | Maryville, TN, United States | Manufacturer | 1 | December 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sun Nuclear Corporation | Melbourne, FL, United States | Manufacturer | 1 | January 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| Varian Medical Systems, Inc | Palo Alto, CA, United States | Manufacturer | 1 | February 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Anholt Technologies Inc. | Avondale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diacor, Inc. | Mount Pleasant, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech America, Inc. Radiation Therapy Division | Santa Clara, CA, United States | Contract manufacturer | 0 | 0 | 3 | 0 | api.fda.gov |
Updated November 3, 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.