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Nucletron Corp.

Also registered as Nucletron, Nucletron Corporation

United StatesFDA applicant, unverified

Devices
49
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Nucletron Corp. makes

Nucletron Corp. manufactures applicator sets for brachytherapy, including prostate, vaginal, and nasopharyngeal applicators, as well as mould applicators for intracavitary treatments. Their portfolio also includes seed-based radioactive implants like the Select Seed I-125 and the Seed Selectron system. Software solutions such as the Plato Brachytherapy planning system and Plato SRS for stereotactic radiosurgery are part of their offerings, alongside imaging tools like the Oldelft Thorascan and Oncentra-Visir. Additional products include the LumenCath applicator sets and catheters, as well as the Integrated Brachy Therapy Unit (IBU).

The company’s devices are classified under Class II in the US and are listed via the FDA’s 510(k) pathway. These products are intended for radiation therapy planning, delivery, and imaging in oncology. Nucletron Corp. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue49

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FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Nucletron Corp., the earliest on 2017-08-10 and the most recent on 2019-11-18. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2019

    • 18 Nov 2019 Z-0772-2020 Class II Terminated A component failure may lead to treatment interruption or incorrect source positioning. Distribution: Distribution in United States and worldwide Submission number: K070574

  • 2017

    • 10 Aug 2017 Z-0050-2018 Class II Terminated Incorrect source step size may occur in the software plans Distribution: Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia,…
      Full distribution text Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.
      Submission number: K132816

Frequently asked questions

How many devices does Nucletron Corp. have in the registry?

The registry currently lists 49 devices for Nucletron Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nucletron Corp.'s devices?

Among its 49 most recently registered devices, Nucletron Corp. has devices listed in FDA 510(k) (49 devices).

What risk classes do Nucletron Corp.'s devices fall under?

Among its 49 most recently registered devices, the classes recorded for Nucletron Corp.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Nucletron Corp.?

FDA recall records list 2 recalls initiated by Nucletron Corp., the most recent initiated on 18 Nov 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Nucletron Corp. in the registry?

The most recently registered devices listed for Nucletron Corp. include CET PROSTATE APPLICATOR SET, PART NUMBER 089.066, STANDARD CT/MR APPLICATOR SET, RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE, ONCENTRA PROSTATE 4.0 and OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY).

Generated automatically from registry data and not verified by a human reviewer.