Nucletron BV

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
41
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0772-2020Class IIThere is a complaint regarding internal check cable guide mechanism failure for the Nucletron FlexitNovember 18, 2019
Z-0050-2018Class IIOncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. OnceAugust 10, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K251037Rectal ApplicatorDecember 19, 2025
K213942EsteyaJanuary 11, 2022
K201272GenevaJuly 16, 2020
K161688Advanced Gynecological ApplicatorJanuary 27, 2017
K151272Henschke Titanium Applicator SetJune 23, 2015
K142439Martinez Prostate Template SetMarch 10, 2015
K140803LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJune 26, 2014
K132816ONCENTRA BRACHYJune 13, 2014
K132889FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)February 26, 2014
K132874LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMFebruary 21, 2014
K132092ESTEYASeptember 26, 2013
K113102ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNINGDecember 12, 2011
K112420ONCENTRA PROSTATE 4.0November 18, 2011
K111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SETSeptember 21, 2011
K092804MICROSELECTRON HDR V2, MODEL 105.999October 8, 2009
K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSJune 29, 2009
K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALSeptember 14, 2007
K041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001March 24, 2005
K041933MICROSELECTRON PDRAugust 18, 2004
K041719ONCENTRA-VISIRJuly 22, 2004