Nucletron Corp.
Medical device manufacturer in Veenendaal, Neth.
49510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K113102 | Oncentra Manual Low Dose Rate Treatment PlanningMUJ · Traditional | 12/12/2011SE |
| K112420 | Oncentra Prostate 4.0JAQ · Traditional | 11/18/2011SE |
| K111973 | Vaginal CT / MR Multi Channel Applicator SetJAQ · Special | 09/21/2011SE |
| K103515 | Equal DoseMUJ · Traditional | 09/15/2011SE |
| K092804 | Microselectron HDR V2, Model 105.999JAQ · Special | 10/08/2009SE |
| K091598 | Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath CathetersJAQ · Special | 06/29/2009SE |
| K090706 | Oncentra Simulation 2.3KPQ · Traditional | 06/15/2009SE |
| K091154 | Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring…JAQ · Special | 05/18/2009SE |
| K082642 | Oncentra RT Viewer 1.0MUJ · Traditional | 11/07/2008SE |
| K080934 | Vienna Ring Ct/Mr Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium…JAQ · Traditional | 05/28/2008SE |
| K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy)MUJ · Traditional | 05/20/2008SE |
| K080871 | Trocar Point Titanium Needle Sets, Round Point Titanium Needle SetsJAQ · Special | 04/29/2008SE |
| K080929 | Oncentra GynMUJ · Traditional | 04/16/2008SE |
| K073273 | Equal Dose 1.0IYE · Traditional | 12/11/2007SE |
| K073107 | Valencia Skin Applicator Set, Model: 189.701JAQ · Special | 12/07/2007SE |
| K072445 | Integrated Brachytherapy Unit - DigitalKPQ · Special | 09/14/2007SE |
| K061354 | Microselectron V3, Model 106.990JAQ · Special | 08/17/2006SE |
| K060349 | Proguide Needle SetJAQ · Special | 03/10/2006SE |
| K052228 | Smit SleeveJAQ · Traditional | 11/09/2005SE |
| K052361 | Simulix-Evolution with Oncentra ConebeamKPQ · Special | 10/24/2005SE |
| K041715 | Intracavitary Mould Applicator Set, Model 189.001JAQ · Traditional | 03/24/2005SE |
| K041933 | Microselectron PDRJAQ · Special | 08/18/2004SE |
| K041719 | Oncentra-VisirMUJ · Special | 07/22/2004SE |
| K033470 | Simulix EvolutionKPQ · Special | 02/04/2004SE |
| K032372 | Nucletron Comfort Catheter System, Model 189.007JAQ · Traditional | 08/15/2003SE |
| K031349 | Otp 1.2MUJ · Special | 08/07/2003SE |
| K031158 | Swift 2.0, Model 132.001JAQ · Special | 08/07/2003SE |
| K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002JAQ · Special | 10/25/2002SE |
| K022741 | Spot Pro (220V), Model 131.099MUJ · Special | 10/24/2002SE |
| K022635 | Kuske Breast Applicator Set, Model 189.006JAQ · Special | 09/06/2002SE |
| K021286 | Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and…JAQ · Special | 05/23/2002SE |
| K020015 | Implant Guidance System Applicator SetJAQ · Special | 03/13/2002SE |
| K010032 | Seed Selectron Model V. 1.0JAQ · Traditional | 10/17/2001SE |
| K012165 | Oldelft Thorascan Model Number 180TKPR · Traditional | 09/19/2001SE |
| K010784 | Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion…MUJ · Special | 04/10/2001SE |
| K002429 | Select Seed I-125KXK · Traditional | 02/02/2001SE |
| K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067JAQ · Special | 12/22/2000SE |
| K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0MUJ · Traditional | 03/27/2000SE |
| K992434 | Itp, Model 1.0MUJ · Traditional | 01/13/2000SE |
| K990990 | Cet Prostate Applicator Set, Part Number 089.066JAQ · Traditional | 10/07/1999SE |
| K983338 | Freiburg Flap Applicator Set, Part Number 089.095JAQ · Traditional | 04/20/1999SE |
| K983341 | Standard Ct/Mr Applicator Set,Ring Ct/Mr Applicator Set, Vaginal Ct/Mr Applicator Set…JAQ · Traditional | 04/15/1999SE |
| K983343 | Plato Brachytheraphy, Model V. 14.0MUJ · Traditional | 04/02/1999SE |
| K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068JAQ · Traditional | 04/02/1999SE |
| K983115 | Treatment Control Station - Microselectron-Hdr Classic Upgrade, Version 1.20JAQ · Traditional | 04/02/1999SE |
| K980629 | VSS, Virtual Simulation SystemIYE · Traditional | 05/06/1998SE |
| K973848 | Ibu, Integrated Brachy Therapy UnitKPQ · Traditional | 01/22/1998SE |
| K964206 | Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2IYE · Traditional | 06/20/1997SE |
| K940001 | Plato-Srs(Stereo Radiosurgery Treatment Planning Sys)IYE · Traditional | 11/14/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0772-2020 Class II | There is a complaint regarding internal check cable guide mechanism failure for the…A component failure may lead to treatment interruption or incorrect source positioning. | 11/18/2019Terminated |
| Z-0050-2018 Class II | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron…Incorrect source step size may occur in the software plans | 08/10/2017Terminated |