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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Varian Medical Systems, IncPalo Alto, CA, United StatesComplaint file establishment, Manufacturer, Specification developer33January 21, 20260880api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesComplaint file establishment, Manufacturer, Specification developer28March 31, 2023010api.fda.gov
Medtec LLCOrange City, IA, United StatesManufacturer, Specification developer16May 20, 2021040api.fda.gov
Sun Nuclear CorporationMelbourne, FL, United StatesManufacturer15October 25, 2017010api.fda.gov
Varian Medical Systems, Inc.San Jose, CA, United StatesManufacturer12June 3, 2022000api.fda.gov
Aktina Medical Corp.Congers, NY, United StatesManufacturer10September 25, 2019000api.fda.gov
Accuray IncorporatedMadison, WI, United StatesManufacturer7June 23, 20230160api.fda.gov
Radformation, Inc.New York, NY, United StatesManufacturer6August 31, 2026000api.fda.gov
Carbon Medical Technologies, Inc.Saint Paul, MN, United StatesComplaint file establishment, Manufacturer5June 10, 2021010api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5April 28, 2017000api.fda.gov
Klarity Medical Products, LLCHeath, OH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer5November 1, 2022010api.fda.gov
Mick Radio-Nuclear Instruments, Inc.Mount Vernon, NY, United StatesManufacturer5February 14, 2000000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer, Repackager or relabeler5April 4, 2018010api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer3March 17, 1999000api.fda.gov
Prowess, Inc.Concord, CA, United StatesManufacturer3September 28, 2021000api.fda.gov
CNMC Co., Inc.Nashville, TN, United StatesManufacturer2August 7, 2018000api.fda.gov
Doseoptics LLCLebanon, NH, United StatesComplaint file establishment, Specification developer2March 29, 2024000api.fda.gov
Philips Medical Systems (Cleveland), Inc.Gainesville, FL, United StatesComplaint file establishment, Specification developer2April 8, 1996000api.fda.gov
Zap Surgical Systems Inc.San Carlos, CA, United StatesComplaint file establishment, Manufacturer2November 3, 2025020api.fda.gov
Akesis Inc.Concord, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1November 2, 2021000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer1December 19, 2017000api.fda.gov
Carina Medical LLCAshburn, VA, United StatesManufacturer1May 13, 2022000api.fda.gov
Chabner XRT, LLCPort Chester, NY, United StatesManufacturer1June 14, 2013000api.fda.gov
Cortex Manufacturing, LLCByhalia, MS, United StatesManufacturer1February 24, 2010000api.fda.gov
CQ Decimal, LLCSanford, FL, United StatesManufacturer1November 22, 2002000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesManufacturer1August 22, 1996000api.fda.gov
Radialogica LLCClayton, MO, United StatesManufacturer1April 4, 2018000api.fda.gov
Radiation Products Design, Inc.Albertville, MN, United StatesManufacturer1September 16, 2015000api.fda.gov
Radiological Imaging Technology, Inc.Co Spgs, CO, United StatesManufacturer1July 29, 1994000api.fda.gov
Reflexion Medical, Inc.Hayward, CA, United StatesComplaint file establishment, Manufacturer1March 12, 2020010api.fda.gov
Surgical Radiation Products LLCNorth Palm Beach, FL, United StatesSpecification developer1July 18, 2018000api.fda.gov
Viewray Systems, Inc.Oakwood Village, OH, United StatesComplaint file establishment, Manufacturer1December 14, 2021060api.fda.gov
Viscus Biologics, LLC.Cleveland, OH, United StatesManufacturer1February 27, 2019000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
Diacor, Inc.Mount Pleasant, UT, United StatesManufacturer0000api.fda.gov
Empnia Inc.Eden Prairie, MN, United StatesManufacturer0000api.fda.gov
Enpak LLCWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Lifeline Software, Inc.Tyler, TX, United StatesManufacturer0000api.fda.gov
Mim Software Inc.Cleveland, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Moldworks Worldwide LLCFords, NJ, United StatesContract manufacturer0000api.fda.gov
Myrava, LLCParma, OH, United StatesContract manufacturer0000api.fda.gov
Quality ElectrodynamicsMayfield Village, OH, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.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.