510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nucletron BV

VEENENDAAL Utrecht, NL

NUCLETRON B.V. appears in FDA device records in VEENENDAAL Utrecht, NL. FDA records list 61 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
61
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

Showing 50 of 61

FDA records hold 61 510(k) clearances for Nucletron BV between 1995 and 2026. The busiest year on record is 1999, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nucletron BV, by decision year
YearClearances
19951
19971
19982
19996
20003
20014
20025
20033
20043
20053
20062
20073
20085
20094
20114
20131
20144
20152
20171
20201
20221
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K262383LumenCare AzureJAQSubstantially Equivalent
K251037Rectal ApplicatorJAQSubstantially Equivalent
K213942EsteyaJADSubstantially Equivalent
K201272GenevaJAQSubstantially Equivalent
K161688Advanced Gynecological ApplicatorJAQSubstantially Equivalent
K151272Henschke Titanium Applicator SetJAQSubstantially Equivalent
K142439Martinez Prostate Template SetJAQSubstantially Equivalent
K140803LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJAQSubstantially Equivalent
K132816ONCENTRA BRACHYMUJSubstantially Equivalent
K132889FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)JAQSubstantially Equivalent
K132874LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMJAQSubstantially Equivalent
K132092ESTEYAJADSubstantially Equivalent
K113102ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNINGMUJSubstantially Equivalent
K112420ONCENTRA PROSTATE 4.0JAQSubstantially Equivalent
K111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SETJAQSubstantially Equivalent
K103515EQUAL DOSEMUJSubstantially Equivalent
K092804MICROSELECTRON HDR V2, MODEL 105.999JAQSubstantially Equivalent
K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSJAQSubstantially Equivalent
K090706ONCENTRA SIMULATION 2.3KPQSubstantially Equivalent
K091154UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,JAQSubstantially Equivalent
K082642ONCENTRA RT VIEWER 1.0MUJSubstantially Equivalent
K080934VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SETJAQSubstantially Equivalent
K081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)MUJSubstantially Equivalent
K080871TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETSJAQSubstantially Equivalent
K080929ONCENTRA GYNMUJSubstantially Equivalent
K073273EQUAL DOSE 1.0IYESubstantially Equivalent
K073107VALENCIA SKIN APPLICATOR SET, MODEL: 189.701JAQSubstantially Equivalent
K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALKPQSubstantially Equivalent
K061354MICROSELECTRON V3, MODEL 106.990JAQSubstantially Equivalent
K060349PROGUIDE NEEDLE SETJAQSubstantially Equivalent
K052228SMIT SLEEVEJAQSubstantially Equivalent
K052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMKPQSubstantially Equivalent
K041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001JAQSubstantially Equivalent
K041933MICROSELECTRON PDRJAQSubstantially Equivalent
K041719ONCENTRA-VISIRMUJSubstantially Equivalent
K033470SIMULIX EVOLUTIONKPQSubstantially Equivalent
K032372NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007JAQSubstantially Equivalent
K031349OTP 1.2MUJSubstantially Equivalent
K031158SWIFT 2.0, MODEL 132.001JAQSubstantially Equivalent
K022739REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002JAQSubstantially Equivalent
K022741SPOT PRO (220V), MODEL 131.099MUJSubstantially Equivalent
K022635KUSKE BREAST APPLICATOR SET, MODEL 189.006JAQSubstantially Equivalent
K021286MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICESJAQSubstantially Equivalent
K020015IMPLANT GUIDANCE SYSTEM APPLICATOR SETJAQSubstantially Equivalent
K010032SEED SELECTRON MODEL V. 1.0JAQSubstantially Equivalent
K012165OLDELFT THORASCAN MODEL NUMBER 180TKPRSubstantially Equivalent
K010784PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1MUJSubstantially Equivalent
K002429SELECT SEED I-125KXKSubstantially Equivalent
K003270PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067JAQSubstantially Equivalent
K992303SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0MUJSubstantially Equivalent

Registered establishments

FDA registered establishments for Nucletron BV, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96118943002807741NUCLETRON B.V.3900 AX VEENENDAAL, P.O. BOX 930, VEENENDAAL Utrecht 3905 TH NL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0772-2020There 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 became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.A component failure may lead to treatment interruption or incorrect source positioning.Class IITerminated
Z-0050-2018Oncentra 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 purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.Incorrect source step size may occur in the software plansClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain