FDA.report

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
34
Last updated
2024-09-26 07:44:00

Related Product Codes

CodeDeviceSpecialtyClassDevices
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology234

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
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-60Eckert & Ziegler BEBIG GmbH1321-02012016-10-04
04049223114978SagiNova® Ir, HDR Afterloader, 25 channels, for IrEckert & 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
00816389020399Afterloader Basic Device GammaMedplus 230 Volt, Series iXVarian Medical Systems Deutschland GmbHGM840002802016-09-16
00816389020405Afterloader Basic Device GammaMedplus 3/24,115V, Series iXVarian Medical Systems Deutschland GmbHGM840002902016-09-16
00816389020412Afterloader Basic Device GammaMedplus 3/24,230V, Series iXVarian Medical Systems Deutschland GmbHGM840003002016-09-16
00816389027312Afterloader Basic Device GammaMedplus 127 Volt, Series iXVarian Medical Systems Deutschland GmbHGM840005102016-09-16
00816389027329Afterloader Basic Device GammaMedplus 3/24, 127V,Series iXVarian Medical Systems Deutschland GmbHGM840005602016-09-16
00816389027947Bravos Afterloader SystemVarian Medical Systems Deutschland GmbHVG150005002018-11-16