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Sign in to claim this brandNucletron B.V.
US
Last updated May 24, 2026
What Nucletron B.V. makes
The company manufactures remote-afterloading brachytherapy systems, including applicators for cervical, prostate, and vaginal treatments, as well as implantable radiological image markers and low-voltage therapeutic X-ray systems for skin tumours. These systems feature components like applicator clamps, titanium applicators, and operator consoles designed for precise radiation delivery in oncology. Example products include the Flexitron, Henschke Titanium Applicators, and X-ray catheters, which integrate with digital control units such as the MicroSelectron Digital.
The portfolio consists of Class II medical devices, regulated under the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. regulatory requirements. The company operates from the United States, adhering to applicable domestic standards for brachytherapy and radiation therapy equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nucletron B.V. manufacture?
Nucletron B.V. specializes in remote-afterloading brachytherapy systems, which are used in radiation oncology. Their portfolio includes applicators for cervical, prostate, and vaginal treatments, as well as implantable radiological image markers and low-voltage therapeutic X-ray systems for skin tumours. These systems are designed for precise radiation delivery and include components like applicator clamps, titanium applicators, and operator consoles. Examples include the Flexitron, Henschke Titanium Applicators, and X-ray catheters.
Where is Nucletron B.V. based, and what regulatory standards do they follow?
Nucletron B.V. is based in the United States. Their devices are developed and manufactured in compliance with U.S. regulatory requirements, including those for brachytherapy and radiation therapy equipment. Since their products fall under Class II classification, they are subject to the FDA’s Unique Device Identification (UDI) system, ensuring traceability and adherence to domestic standards.
Which regulatory registries or databases list Nucletron B.V.’s devices?
Nucletron B.V.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures that each product is traceable and meets U.S. regulatory compliance requirements, particularly for Class II medical devices like their brachytherapy systems and related applicators.
How are Nucletron B.V.’s devices classified under U.S. regulations?
Nucletron B.V.’s devices are classified as Class II medical devices under U.S. regulations. This classification applies to their remote-afterloading brachytherapy systems, applicators, and related components, which require special controls to ensure safety and effectiveness in radiation therapy applications. The FDA’s UDI system further tracks these devices to maintain compliance and transparency.
What distinguishes Nucletron B.V.’s brachytherapy systems from other radiation therapy solutions?
Nucletron B.V.’s brachytherapy systems are distinguished by their remote-afterloading technology, which allows precise and controlled delivery of radiation directly to tumours while minimizing exposure to surrounding healthy tissue. Their portfolio includes specialized applicators for cervical, prostate, and vaginal treatments, as well as digital operator consoles like the MicroSelectron Digital, which enhance accuracy and customization. This focus on targeted radiation therapy sets them apart in oncology solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- elekta.com
- —
- —
- [email protected]
- Phone
- +1(770)300-9725
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 415269930
Catalogue (1917)
Page 39 of 39| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cervix Rotterdam Applicator | 137256P01-01 | FDA UDI | Class II | Active |
| X-ray Catheters | 089402P01-01 | FDA UDI | Class II | Active |
| Cervix Rotterdam Applicator | 137535-01 | FDA UDI | Class II | Active |
| Breast Template Set | 045260P01 | FDA UDI | Class II | Active |
| Breast Template Set | 045137P01 | FDA UDI | Class II | Active |
| Interstitial needles | 083072P02-00 | FDA UDI | Class II | Active |
| Esteya | K213942 | FDA 510(k) | Class II | Active |
| Geneva | K201272 | FDA 510(k) | Class II | Active |
| Advanced Gynecological Applicator | K161688 | FDA 510(k) | Class II | Active |
| Lumencare Azure Set F6, 150cm, Lumecare Azure Set 5f, 150 Cm, Lumencare Azure Set 5f, 140 Cm | K132874 | FDA 510(k) | Class II | Active |
| Henschke Titanium Applicator Set | K151272 | FDA 510(k) | Class II | Active |
| Fletcher Ct/Mr Shielded Applicator Set (6 Mm) Fletcher Ct/Mr Shielded Applicator Set (4 Mm) | K132889 | FDA 510(k) | Class II | Active |
| Oncentra Brachy | K132816 | FDA 510(k) | Class II | Active |
| Rectal Applicator | K251037 | FDA 510(k) | Class II | Active |
| Martinez Prostate Template Set | K142439 | FDA 510(k) | Class II | Active |
| Luneray;catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm | K140803 | FDA 510(k) | Class II | Active |
| Esteya | K132092 | FDA 510(k)FDA UDI | Class II | Active |
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