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Data / Medical devices / System, Planning, Radiation Therapy Treatment / United States

FDA-registered makers of System, Planning, Radiation Therapy Treatment in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make System, Planning, Radiation Therapy Treatment (product code MUJ). 14 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
System, Planning, Radiation Therapy Treatment
Product code
MUJ
Country
United States

Makers of System, Planning, Radiation Therapy Treatment in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Prowess, Inc.Concord, CA, United StatesManufacturer7December 15, 2023000api.fda.gov
CQ Decimal, LLCSanford, FL, United StatesManufacturer5July 1, 2021000api.fda.gov
Philips Medical Systems (Cleveland), Inc.Gainesville, FL, United StatesComplaint file establishment, Manufacturer, Specification developer5February 9, 2017030api.fda.gov
Best NomosPittsburgh, PA, United StatesComplaint file establishment, Manufacturer2May 6, 2021000api.fda.gov
Radformation, Inc.New York, NY, United StatesManufacturer2December 19, 2025000api.fda.gov
Varian Medical Systems, IncPalo Alto, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2February 12, 20210240api.fda.gov
Carina Medical LLCAshburn, VA, United StatesManufacturer1April 8, 2022000api.fda.gov
Empyrean Medical Systems, Inc.Boca Raton, FL, United StatesSpecification developer1February 21, 2019000api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer1August 25, 2022000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesSpecification developer1August 25, 2022000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesManufacturer1April 8, 2010000api.fda.gov
Lifeline Software, Inc.Tyler, TX, United StatesManufacturer1December 31, 2019000api.fda.gov
Sun Nuclear CorporationMelbourne, FL, United StatesManufacturer1April 11, 2025000api.fda.gov
The University of Texas MD Anderson Cancer Center, Department of Radiation Physics, Division of Radiation OncologyHouston, TX, United StatesManufacturer1May 17, 2023000api.fda.gov
Accuray IncorporatedMadison, WI, United StatesManufacturer0080api.fda.gov
Extol, IncZeeland, MI, United StatesContract manufacturer0000api.fda.gov
Mim Software Inc.Cleveland, OH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Reflexion Medical, Inc.Hayward, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Zap Surgical Systems Inc.San Carlos, CA, United StatesComplaint file establishment, Manufacturer0000api.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.