Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611894

FEI Number

3002807741

Entity Name

NUCLETRON B.V.

City/State/Country

VEENENDAAL Utrecht, NL

Establishment Address

3900 AX VEENENDAAL, P.O. BOX 930, Waardgelder 1, VEENENDAAL Utrecht 3905 TH, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nucletron B.V. (Owner Number: 8030474)

Owner / Operator Contact Address

3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1, Veenendaal, NL-UT 3905 TH, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140803

PMA Number

N/A

All Registered Proprietary Names

Advanced Gynecological Applicator Leksell Stereotactic System Vaginal CT/MR Multi Channel Applicator Set Catheter Set with Collar 6Fx293 mm Esteya Bonvoisin Gerard Esophageal Applicator Set Martinez Prostate Template set Cervix Ring Applicator set Smit Sleeve CT/MR Smit Sleeve Henschke Titanium Applicator Set Flexible Implant Tube CT/MR OncoSmart Catheter Sets OncoSmart Catheter System OncoSmart Flange Molding Set Valencia Ft Skin Applicator Set Valencia Skin Applicator Set Esteya Vienna Ring CT/MR Applicator Set Round Point Titanium Needle Set Trocar Point Titanium Needle Set Guiding Tube for Ring Set for Interstitial Ring MR Line Marker Utrecht Interstitial Fletcher CT/MR Applicator Set Interstitial Ring CT/MR Applicator set Utrecht Interstitial CT/MR Applicator set Guiding Tube for Ovoids Kuske Breast Applicator Set Breast CT/MR Template Set Kuske Breast Template Set CT Markers Set Oncentra External Beam Oncentra Masterplan Oncentra Masterplan Oncentra Brachy FREIBURG FLAP APPLICATOR SET ProGuide Needle OncoSelect Stepper Laptop Cart Oncentra Seeds ERCM - EndoCavity Rotational Mover Oncentra Prostate FLETCHER WILLIAMSON APPLICATOR SET Fletcher CT/MR Applicator Set XS RING CT/MR APPLICATOR SET STANDARD CT/MR APPLICATOR SET Fletcher CT/MR Applicator Set VAGINAL CT/MR APPLICATOR SET Vaginal Cylinder applicator Flexisource and Check Cable Bronchial Catheter Adapter Flexitron Transfer Tubes Cervix Rotterdam Applicators X-ray markers Ti vaginal Cylinder applicator set Source Position Check Ruler (SPCR) ROTTERDAM NASOPHARYNX MOULD SET INTRACAVITARY MOULD APPLICATOR SET Ft INTRACAVITARY MOULD APPLICATOR SET Leksell Vantage Stereotactic System Ir-192 source CT/MR Applicator Clamp Fritz Adjustable Intralumenal Appl. Set Basic Rotte Endometrial Applicator Set MUPIT Applicator Set Horiot Endometrial Applicator Set Norman Simon Applicator Set Standard Shielded Applicator Set Bonvoisin-Gerard Applicator Set Brain, Flexible Implant Needle Set Novi Sad Inflatable Rectal Applicator Set Catheter Insertion Set, 6F Trocar Nasopharyngeal Applicator Set NAG Brachyflex Set Catheter Insertion Set, 6F Bevel Demanes Rodriquez Applicator Set Ring Applicator Set Rotte Endometrial Applicator Set Lumencath Applicator Set Speiser Needle Insertion System Pipard Tounge Template Set Shielded Cylindrical Applicator Set Fritz Adjustable Intralumenal Applicator Set Fritz Adjustable Intralumenal Applicator Flexiguide Needle Set Super Mould Applicator Set Leipzig Applicator Set Selectron Standard Applicator Set Selectron Standard Shielded Applicator Set Pencil point needles Interstitial Needle Set Pancreatic Flexible Needle Set Martinez Endometrial Applicator Set Brain Needle Set with Fixing Tool Miami Vaginal Applicator Set Porter Perineal Applicator Set Arnhem Bile Duct Applicator Bladder Applicator Set Basic Norman Simon Applicator Set Trocar needles Flexible Implant Tube Set Rowland Oesophageal Applicator Set Henschke Applicator Set Houdek Applicator Set Bevel needles Catheter Deflection Set Template Set, Breast Implants (complete) Rotte Applicator Set Vaginal Applicator Set Oesophageal Applicator Set Standard Nasopharyngeal Applicator Set Interstitial Needle Basic Set Surface Mould Applicator Set Oncentra Brachy Luneray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-01-30
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-09-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2011-09-26
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2013-10-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2010-11-22
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2015-06-24
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2022-01-20
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2014-12-17
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2012-07-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-12-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2010-11-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2012-07-05
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-05-09
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2011-06-28
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2014-06-20
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Valentine Business: Elekta Email: Thomas.Valentine@elekta.com Phone: (404) 7972537

Related Public Records

Same Entity

Nucletron B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611894. Last updated year: 2026. Please use registration number 9611894 when referencing this establishment in official correspondence.