FDA.reportPublic FDA data

Remote-afterloading brachytherapy system

Definition
An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.
GUDID devices
86
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08717213013117MicroSelectron DigitalNucletron B.V.096035-042016-09-10
08717213015746MicroSelectron DigitalNucletron B.V.111094-022016-10-13
08717213018686NANucletron B.V.130019-102016-09-24
08717213020085NANucletron B.V.131400-012016-09-10
08717213020467microSelectron DigitalNucletron B.V.1069902018-06-05
08717213022232FlexitronNucletron B.V.136196-022017-01-05
08717213022409NANucletron B.V.137818-002016-10-27
08717213023956NANucletron B.V.130025-062016-09-23
08717213023963NANucletron B.V.130039-002016-09-10
08717213024083NANucletron B.V.130039P01-002016-09-10
08717213024090NANucletron B.V.130039P02-002016-09-10
08717213028647NANucletron B.V.130042-002016-09-10
08717213028654NANucletron B.V.130045-012017-05-25
08717213033986MicroSelectron DigitalNucletron B.V.111097-012018-06-14
08717213033993MicroSelectron DigitalNucletron B.V.111096-012016-10-13
08717213034006FlexitronNucletron B.V.138200-002016-10-13
08717213034013FlexitronNucletron B.V.138201-002018-06-14
08717213034037FlexitronNucletron B.V.138202-002016-10-13
08717213034044FlexitronNucletron B.V.138203-002018-06-14
08717213034143MicroSelectron DigitalNucletron B.V.111095-012018-06-14
08717213036352NANucletron B.V.131401-002016-09-10
08717213036390NANucletron B.V.131055A01-062017-01-07
08717213036406NANucletron B.V.131055A02-062016-11-23
08717213036529seedSelectronNucletron B.V.130001-152016-11-23
08717213036550MicroSelectron DigitalNucletron B.V.096035P01-042016-09-10
08717213036567NANucletron B.V.073250P01-022016-09-23
08717213037731NANucletron B.V.137180-002016-12-01
08717213037755NANucletron B.V.137182-002016-12-01
08717213037779NANucletron B.V.137810-002018-06-14
08717213039124NANucletron B.V.137040-002016-10-27
08717213039131NANucletron B.V.137041-002016-10-27
08717213039148NANucletron B.V.137042-002016-10-27
08717213039155NANucletron B.V.137043-002016-10-27
08717213039452MicroSelectron DigitalNucletron B.V.111268P01-012016-10-13
08717213039469MicroSelectron DigitalNucletron B.V.111275P01-032016-10-13
08717213039544NANucletron B.V.130512P01-002016-10-27
08717213039735FlexitronNucletron B.V.138225P01-002016-10-13
08717213039742FlexitronNucletron B.V.138227P01-002016-10-13
08717213041431MicroSelectron DigitalNucletron B.V.096004P01-002016-12-01
08717213041547FlexitronNucletron B.V.136199P01-002016-10-27
08717213043794NANucletron B.V.130038-052017-05-25
08717213050013selectSpacerNucletron B.V.130335-002016-10-11
08717213050020NANucletron B.V.130334-002016-10-11
08717213050815NANucletron B.V.096271A02-002016-09-23
08717213050822NANucletron B.V.096271A10-002016-09-23
08717213051126Flexitron HDRNucletron B.V.1361492016-09-26
08717213051140microSelectron DigitalNucletron B.V.1069902016-09-26
08717213051157seedSelectronNucletron B.V.130053P012017-01-17
08717213052826NANucletron B.V.130512C-002018-07-11
08717213052895NANucletron B.V.130512P01-012018-07-11
08717213056954NANucletron B.V.131055A01-072022-01-06
08717213056961NANucletron B.V.131055A02-072022-01-06
04065983002850Disposable steel needle, 17G, L=200mmBEBIG Medical GmbH052024-09-18
04065983000986Transfer Tube, D=3mm, L=1000mmBEBIG Medical GmbH062024-04-26
04065983000993Transfer Tube, D=3mm, L=1000mm, Green, Channel 1BEBIG Medical GmbH062024-04-26
04065983001006Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2BEBIG Medical GmbH062024-04-26
04065983001013Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3BEBIG Medical GmbH062024-04-26
04065983001020Transfer Tube, D=3mm, L=1000mm, T-connectorBEBIG Medical GmbH012024-04-26
04065983001037Transfer Tube, D=3mm, L=1000mm, Green, Channel 1, T-connectorBEBIG Medical GmbH012024-04-26
04065983001044Transfer Tube, D=3mm, L=1000mm, Yellow, Channel 2, T-connectorBEBIG Medical GmbH012024-04-26
04065983001051Transfer Tube, D=3mm, L=1000mm, Blue, Channel 3, T-connectorBEBIG Medical GmbH012024-04-26
04065983001068Easy Click Transfer Tube, D=3mm, L=1000mmBEBIG Medical GmbH032024-04-26
04065983001075Easy Click Transfer Tube 6F, D=3mm, L=1000mmBEBIG Medical GmbH032024-04-26
04065983001082Connector for Universal Applicator, D=2.0mm (EasyClick 6F)BEBIG Medical GmbH012024-04-26
04065983000023SagiNova® 25 channels, for Co-60 and Ir-192BEBIG Medical GmbH062024-01-24
04065983000030SagiNova® Ir 25 channels, for Ir-192 onlyBEBIG Medical GmbH062024-01-24
00816389029200BRAVOS Afterloader SystemVarian Medical Systems Deutschland GmbH1.22022-09-23
00816389028197Varian BRAVOS Afterloader SystemVARIAN MEDICAL SYSTEMS, INC.1.12020-01-10
08717213018693NANucletron B.V.130040-012016-09-10
08717213023925NANucletron B.V.130020-062016-09-23
08717213023932NANucletron B.V.130023-032016-09-23
08717213023949NANucletron B.V.130024-022016-09-23
08717213024106NANucletron B.V.130040P02-012016-09-10
08717213024113NANucletron B.V.130040P01-012016-09-10
08717213030473NANucletron B.V.130025-062016-09-23
04049223114961SagiNova®, HDR Afterloader, 25 channels, for Co-60 and Ir-192Eckert & Ziegler BEBIG GmbH1321-02012016-10-04
04049223114978SagiNova® Ir, HDR Afterloader, 25 channels, for Ir-192 onlyEckert & Ziegler BEBIG GmbH1321-02022016-10-04
00856545006027VariSource iXVARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED1.22016-09-16
00856545006034VariSource iX(t)VARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED1.22016-09-16
00816389020382Afterloader Basic Device GammaMedplus 115 Volt, Series iXVarian Medical Systems Deutschland GmbHGM840002702016-09-16