Company ยท US
Nucletron Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (2 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K262383 | LumenCare Azure Nucletron B.V., NL | JAQ |
| Dec 19, 2025 | K251037 | Rectal Applicator Nucletron B.V., NL | JAQ |
| Jan 11, 2022 | K213942 | Esteya Nucletron B.V., NL | JAD |
| Jul 16, 2020 | K201272 | Geneva Nucletron B.V., NL | JAQ |
| Jan 27, 2017 | K161688 | Advanced Gynecological Applicator Nucletron B.V., NL | JAQ |
| Jun 23, 2015 | K151272 | Henschke Titanium Applicator Set Nucletron B.V., NL | JAQ |
| Mar 10, 2015 | K142439 | Martinez Prostate Template Set Nucletron B.V., NL | JAQ |
| Jun 26, 2014 | K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM Nucletron B.V., NL | JAQ |
| Jun 13, 2014 | K132816 | ONCENTRA BRACHY Nucletron B.V. | MUJ |
| Feb 26, 2014 | K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) Nucletron B.V., NL | JAQ |
| Feb 21, 2014 | K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM Nucletron B.V., NL | JAQ |
| Sep 26, 2013 | K132092 | ESTEYA Nucletron B.V. | JAD |
| Dec 12, 2011 | K113102 | ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING Nucletron | MUJ |
| Nov 18, 2011 | K112420 | ONCENTRA PROSTATE 4.0 Nucletron | JAQ |
| Sep 21, 2011 | K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET Nucletron | JAQ |
| Sep 15, 2011 | K103515 | EQUAL DOSE Nucletron Corporation | MUJ |
| Oct 8, 2009 | K092804 | MICROSELECTRON HDR V2, MODEL 105.999 Nucletron Corp. | JAQ |
| Jun 29, 2009 | K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS Nucletron Corp. | JAQ |
| Jun 15, 2009 | K090706 | ONCENTRA SIMULATION 2.3 Nucletron Corporation | KPQ |
| May 18, 2009 | K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, Nucletron Corporation | JAQ |
| Nov 7, 2008 | K082642 | ONCENTRA RT VIEWER 1.0 Nucletron Corporation | MUJ |
| May 28, 2008 | K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET Nucletron Corporation | JAQ |
| May 20, 2008 | K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) Nucletron Corporation | MUJ |
| Apr 29, 2008 | K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS Nucletron Corporation | JAQ |
| Apr 16, 2008 | K080929 | ONCENTRA GYN Nucletron Corporation | MUJ |
| Dec 11, 2007 | K073273 | EQUAL DOSE 1.0 Nucletron Corporation | IYE |
| Dec 7, 2007 | K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 Nucletron Corporation | JAQ |
| Sep 14, 2007 | K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL Nucletron Corp. | KPQ |
| Aug 17, 2006 | K061354 | MICROSELECTRON V3, MODEL 106.990 Nucletron Corporation | JAQ |
| Mar 10, 2006 | K060349 | PROGUIDE NEEDLE SET Nucletron Corporation | JAQ |
| Nov 9, 2005 | K052228 | SMIT SLEEVE Nucletron Corporation | JAQ |
| Oct 24, 2005 | K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM Nucletron Corporation | KPQ |
| Mar 24, 2005 | K041715 | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 Nucletron Corp. | JAQ |
| Aug 18, 2004 | K041933 | MICROSELECTRON PDR Nucletron Corp. | JAQ |
| Jul 22, 2004 | K041719 | ONCENTRA-VISIR Nucletron Corp. | MUJ |
| Feb 4, 2004 | K033470 | SIMULIX EVOLUTION Nucletron Corporation | KPQ |
| Aug 15, 2003 | K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 Nucletron Corporation | JAQ |
| Aug 7, 2003 | K031349 | OTP 1.2 Nucletron Corp. | MUJ |
| Aug 7, 2003 | K031158 | SWIFT 2.0, MODEL 132.001 Nucletron Corp. | JAQ |
| Oct 25, 2002 | K022739 | REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 Nucletron Corporation | JAQ |
| Oct 24, 2002 | K022741 | SPOT PRO (220V), MODEL 131.099 Nucletron Corporation | MUJ |
| Sep 6, 2002 | K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 Nucletron Corporation | JAQ |
| May 23, 2002 | K021286 | MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES Nucletron Corp. | JAQ |
| Mar 13, 2002 | K020015 | IMPLANT GUIDANCE SYSTEM APPLICATOR SET Nucletron Corp. | JAQ |
| Oct 17, 2001 | K010032 | SEED SELECTRON MODEL V. 1.0 Nucletron Corp. | JAQ |
| Sep 19, 2001 | K012165 | OLDELFT THORASCAN MODEL NUMBER 180T Nucletron Corp. | KPR |
| Apr 10, 2001 | K010784 | PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 Nucletron Corp. | MUJ |
| Feb 2, 2001 | K002429 | SELECT SEED I-125 Nucletron Corp. | KXK |
| Dec 22, 2000 | K003270 | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 Nucletron Corp. | JAQ |
| Mar 27, 2000 | K992303 | SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 Nucletron Corp. | MUJ |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2019 | Nucletron BV 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 in Terminated |
JAQ | K070574 |
| Aug 10, 2017 | Nucletron BV 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 t Terminated |
MUJ | K132816 |