Data / Medical devices / Accelerator, Linear, Medical / United States
FDA-registered makers of Accelerator, Linear, Medical in the United States: 45 establishments
45 establishments in the United States are registered with the FDA to make Accelerator, Linear, Medical (product code IYE). 33 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 3, 2026.
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- Device
- Accelerator, Linear, Medical
- Product code
- IYE
- Country
- United States
Makers of Accelerator, Linear, Medical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Varian Medical Systems, Inc | Palo Alto, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 33 | January 21, 2026 | 0 | 88 | 0 | api.fda.gov |
| Anholt Technologies Inc. | Avondale, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 28 | March 31, 2023 | 0 | 1 | 0 | api.fda.gov |
| Medtec LLC | Orange City, IA, United States | Manufacturer, Specification developer | 16 | May 20, 2021 | 0 | 4 | 0 | api.fda.gov |
| Sun Nuclear Corporation | Melbourne, FL, United States | Manufacturer | 15 | October 25, 2017 | 0 | 1 | 0 | api.fda.gov |
| Varian Medical Systems, Inc. | San Jose, CA, United States | Manufacturer | 12 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Aktina Medical Corp. | Congers, NY, United States | Manufacturer | 10 | September 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Accuray Incorporated | Madison, WI, United States | Manufacturer | 7 | June 23, 2023 | 0 | 16 | 0 | api.fda.gov |
| Radformation, Inc. | New York, NY, United States | Manufacturer | 6 | August 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Carbon Medical Technologies, Inc. | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 5 | June 10, 2021 | 0 | 1 | 0 | api.fda.gov |
| Izi Medical Products LLC | Owings Mills, MD, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Klarity Medical Products, LLC | Heath, OH, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 5 | November 1, 2022 | 0 | 1 | 0 | api.fda.gov |
| Mick Radio-Nuclear Instruments, Inc. | Mount Vernon, NY, United States | Manufacturer | 5 | February 14, 2000 | 0 | 0 | 0 | api.fda.gov |
| Standard Imaging, Inc. | Middleton, WI, United States | Manufacturer, Repackager or relabeler | 5 | April 4, 2018 | 0 | 1 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 3 | March 17, 1999 | 0 | 0 | 0 | api.fda.gov |
| Prowess, Inc. | Concord, CA, United States | Manufacturer | 3 | September 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| CNMC Co., Inc. | Nashville, TN, United States | Manufacturer | 2 | August 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Doseoptics LLC | Lebanon, NH, United States | Complaint file establishment, Specification developer | 2 | March 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems (Cleveland), Inc. | Gainesville, FL, United States | Complaint file establishment, Specification developer | 2 | April 8, 1996 | 0 | 0 | 0 | api.fda.gov |
| Zap Surgical Systems Inc. | San Carlos, CA, United States | Complaint file establishment, Manufacturer | 2 | November 3, 2025 | 0 | 2 | 0 | api.fda.gov |
| Akesis Inc. | Concord, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | December 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Carina Medical LLC | Ashburn, VA, United States | Manufacturer | 1 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Chabner XRT, LLC | Port Chester, NY, United States | Manufacturer | 1 | June 14, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cortex Manufacturing, LLC | Byhalia, MS, United States | Manufacturer | 1 | February 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| CQ Decimal, LLC | Sanford, FL, United States | Manufacturer | 1 | November 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Manufacturer | 1 | August 22, 1996 | 0 | 0 | 0 | api.fda.gov |
| Radialogica LLC | Clayton, MO, United States | Manufacturer | 1 | April 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Radiation Products Design, Inc. | Albertville, MN, United States | Manufacturer | 1 | September 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Radiological Imaging Technology, Inc. | Co Spgs, CO, United States | Manufacturer | 1 | July 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Reflexion Medical, Inc. | Hayward, CA, United States | Complaint file establishment, Manufacturer | 1 | March 12, 2020 | 0 | 1 | 0 | api.fda.gov |
| Surgical Radiation Products LLC | North Palm Beach, FL, United States | Specification developer | 1 | July 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Viewray Systems, Inc. | Oakwood Village, OH, United States | Complaint file establishment, Manufacturer | 1 | December 14, 2021 | 0 | 6 | 0 | api.fda.gov |
| Viscus Biologics, LLC. | Cleveland, OH, United States | Manufacturer | 1 | February 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtronics Corporation | Milford, NH, 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 | |
| Empnia Inc. | Eden Prairie, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enpak LLC | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifeline Software, Inc. | Tyler, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mim Software Inc. | Cleveland, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moldworks Worldwide LLC | Fords, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myrava, LLC | Parma, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Electrodynamics | Mayfield Village, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 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.