Data / Medical devices / Netherlands / Nucletron B.V.
Nucletron B.V.: FDA-registered device maker in VEENENDAAL Utrecht, Netherlands, 32 510(k) clearances
Nucletron B.V. is registered with the FDA (registration 9611894) in VEENENDAAL Utrecht, Netherlands. It lists 5 device types. The FDA files 32 510(k) clearances under its listings, the newest dated July 24, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9611894
- FEI number
- 3002807741
- Address
- 3900 AX VEENENDAAL, P.O. BOX 930 Waardgelder 1, VEENENDAAL Utrecht, Netherlands, 3905 TH
- Owner or operator
- Nucletron B.V. (8030474)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 16, 2008
- Registered through
- 2027
- Brand names listed
- Advanced Gynecological Applicator, Arnhem Bile Duct Applicator, Basic Norman Simon Applicator Set, Basic Rotte Endometrial Applicator Set, Bevel needles, Bladder Applicator Set, Bonvoisin Gerard Esophageal Applicator Set, Bonvoisin-Gerard Applicator Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Therapeutic, X-Ray | JAD | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K262383 | LumenCare Azure | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| December 19, 2025 | K251037 | Rectal Applicator | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| January 11, 2022 | K213942 | Esteya | JAD | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| July 16, 2020 | K201272 | Geneva | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| January 27, 2017 | K161688 | Advanced Gynecological Applicator | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| June 23, 2015 | K151272 | Henschke Titanium Applicator Set | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| March 10, 2015 | K142439 | Martinez Prostate Template Set | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| June 26, 2014 | K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| June 13, 2014 | K132816 | ONCENTRA BRACHY | MUJ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| February 26, 2014 | K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| February 21, 2014 | K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| September 26, 2013 | K132092 | ESTEYA | JAD | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| July 2, 2012 | K121448 | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY | MUJ | Substantially Equivalent | Elekta Inc. D/B/A Nucletron Corporation | accessdata.fda.gov |
| November 18, 2011 | K112420 | ONCENTRA PROSTATE 4.0 | JAQ | Substantially Equivalent | Nucletron | accessdata.fda.gov |
| September 21, 2011 | K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET | JAQ | Substantially Equivalent | Nucletron | accessdata.fda.gov |
| May 18, 2009 | K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| October 30, 2008 | K082530 | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY | JAQ | Substantially Equivalent | Isodose Control B.V. | accessdata.fda.gov |
| May 28, 2008 | K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| April 29, 2008 | K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| December 7, 2007 | K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| April 13, 2007 | K070574 | FLEXITRON | JAQ | Substantially Equivalent | Isodose Control B.V. | accessdata.fda.gov |
| August 17, 2006 | K061354 | MICROSELECTRON V3, MODEL 106.990 | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| March 10, 2006 | K060349 | PROGUIDE NEEDLE SET | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| November 9, 2005 | K052228 | SMIT SLEEVE | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| March 24, 2005 | K041715 | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 | JAQ | Substantially Equivalent | Nucletron Corp. | accessdata.fda.gov |
| August 15, 2003 | K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| September 6, 2002 | K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 | JAQ | Substantially Equivalent | Nucletron Corporation | accessdata.fda.gov |
| December 22, 2000 | K003270 | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 | JAQ | Substantially Equivalent | Nucletron Corp. | accessdata.fda.gov |
| April 20, 1999 | K983338 | FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 | JAQ | Substantially Equivalent | Nucletron Corp. | accessdata.fda.gov |
| April 15, 1999 | K983341 | STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE | JAQ | Substantially Equivalent | Nucletron Corp. | accessdata.fda.gov |
| April 2, 1999 | K983337 | ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 | JAQ | Substantially Equivalent | Nucletron Corp. | accessdata.fda.gov |
| August 13, 1996 | K953946 | MICROSELECTRON-HDR VERSION 2 | JAQ | Substantially Equivalent | Nucletron-Oldelft Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 18, 2019 | 84371 | Class II | Terminated | There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube | A component failure may lead to treatment interruption or incorrect source positioning. | accessdata.fda.gov |
| August 10, 2017 | 78087 | Class II | Terminated | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the | Incorrect source step size may occur in the software plans | accessdata.fda.gov |
Compare with other makers
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Neurological Stereotaxic Instrument
- All makers of System, Therapeutic, X-Ray
- All makers of System, X-Ray, Film Marking, Radiographic
Updated July 24, 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.