iGUIDE - iGUIDE is the control software of the HexaPOD™ evo RT Couchtop. Software Revision 2.2.4
2026-04-22
3C-Medical Intelligence GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710332 | 3003251135 | 3C-Medical Intelligence GmbH | 1 | N | 2026-01-01 | 3C-Ring 1 Landsberg am Lech Bavaria DE 86899 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296906 | 1160784944 | K143485 | iGuide 2.1 | IYE | 2015-03-04 |
| 296906 | 1774634330 | K121530 | BODYFIX SYSTEM | IYE | 2012-06-20 |
| 296906 | 1096634764 | K112210 | FRAXION | IYE | 2011-11-22 |
| 296906 | 1950937251 | K072898 | HEXAPOD EVO RT COUCH TOP | JAI | 2007-10-25 |
| 296906 | 1834767748 | ||||
| 296906 | 1930203432 |
Product Codes Associated With Registrations#
GUDID#
iGUIDE - iGUIDE is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.
2019-08-01
iGUIDE - iGUIDE Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module
2016-08-23
iGUIDE - iGUIDE Software 2.2.1 is the software which controls the movement of the HexaPOD™ evo Module and monitors the correct position of the module.
2017-02-24
iGUIDE - iGUIDE Software 2.2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module
2017-10-13
BodyFIX - BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold tube for hygienic purposes.
2016-08-23
BodyFIX - BodyFIX® Hygienic Drape Manifold Cushion (2x15000mm) is used to cover the vacuum manifold cushion for hygienic purposes.
2016-08-23
Fraxion - The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum.
2016-08-23
Fraxion - The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum.
2016-08-23
HeadFIX - HeadFIX® Saliva Stop is connected between the vacuum pump and the mouthpiece preventing saliva from reaching the vacuum pump.
2016-08-23
HeadFIX - The HeadFIX® Mouthpiece Small P2 is affixed to the HeadFIX Angulating Fixation Set assuring safe immobilization and precise (re-) positioning.
2016-08-23
HeadFIX - The HeadFIX® Mouthpiece X-large P2 is affixed to the HeadFIX Angulating Fixation Set assuring safeimmobilization and precise (re-) positioning.
2016-08-23
HeadFIX - The HeadFIX® Nosepiece set contains five nosepieces for assuring safe immobilization and precise repositioning of the head and neck by the patient’s nose. The HeadFIX® Nosepiece is affixed to the HeadFIX Angulating Fixation Set.
2016-08-23
HeadFIX - The HeadFIX® Mouthpiece Medium is affixed to the HeadFIX Angulating Fixation Set assuring safeimmobilization and precise (re-) positioning.
2016-08-23
HeadFIX - The HeadFIX® Mouthpiece Large is affixed to the HeadFIX Angulating Fixation Set assuring safe immobilization and precise (re-) positioning.
2016-08-23
iBEAM® - iBEAM®evo CT Overlay Siemens Biograph
2020-06-18
iBEAM - iBEAM® evo Couchtop EH is intended to support the patient during radiation therapy or radiation therapy simulation.iBEAM® evo Couchtop EH is compatible to the Elekta Harmony PSS.
2022-07-12
HexaPOD - HexaPOD one Module is a robotic couch top which fine adjusts the tumour position to the ISO center
2021-09-28
iBEAM® - iBEAM® one Couchtop is intended to support the patient during radiation therapy or radiation therapy simulation.
2020-08-20
iBEAM® - iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applications.
2020-07-07
BodyFIX - BodyFIX® Comfort Module 500x200mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body.
2016-08-23
BodyFIX - BodyFIX® Comfort Module 500x400mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body.
2016-08-23
BodyFIX - BodyFIX® 14 Base Plate Stereotactic Standard is specially designed for using BodyFIX stereotactic on non-indexed couchtops.
2016-08-23
BodyFIX - BodyFIX® 14 Base Plate Stereotactic MRI is specially designed for using BodyFIX stereotactic on non-indexed MRI couchtops.
2016-08-23
BodyFIX - BodyFIX® 14 Localizer STANDARD enables precise localization of the tumor isocenter. The x-, y-, z-isocenter coordinates can easily be determined with the rods of the localizer.
2016-08-23
BodyFIX - BodyFIX® 14 Target Positioner STANDARD enables the exact targeting of the tumor isocenter on the linac identified with the localizer on the CT.
2016-08-23
BodyFIX - BodyFIX® Diaphragm Control has been developed to specifically minimize diaphragm movements.
2016-08-23
BodyFIX - BodyFix® Vacuum Pump P3 is a vacuum pump that controls the dual-vacuum technology, used for precise patient positioning and immobilization of the BodyFIX® System.
2016-08-23
BodyFIX - BodyFIX® Manifold Cushion 600mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
2016-08-23
BodyFIX - BodyFIX® Manifold Cushion 700mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
2016-08-23
BodyFIX - BodyFIX® Manifold Cushion 800mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
2016-08-23
BodyFIX - BodyFIX® Manifold Cushion 900mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
2016-08-23
BodyFIX - Together with the Manifold Cushion the BodyFIX® Manifold Tube 1000mm establishes a permanent and equal vacuum over the patient.
2016-08-23
BodyFIX - Together with the Manifold Cushion the BodyFIX® Manifold Tube 1500mm establishes a permanent and equal vacuum over the patient.
2016-08-23
BodyFIX - Together with the Manifold Cushion the BodyFIX® Manifold Tube 2000mm establishes a permanent and equal vacuum over the patient.
2016-08-23
BodyFIX - BodyFIX® Manifold Connector STANDARD is used to attach the manifold cushion to the manifold tube.
2016-08-23
BodyFIX - BodyFIX® Stabilizing Cushion 800x600mm provides improved stabilization of the patient when setting up the vacuum.
2016-08-23
BodyFIX - BodyFIX® Stabilizing Cushion OP-PORTAL provides improved stabilization of the patient when setting up the vacuum.
2016-08-23
BodyFIX - BodyFIX® 14 Marking Set STANDARD contains marking plates for the BodyFIX Target Positioner to assist in patient positioning and light field verification.
2016-08-23
BodyFIX - The BodyFIX Localizer features three Localizer screens specially designed for stereotactic application. Each of these Localizer screens has three slots with special plastic tubes already inserted. As an alternative to the plastic tubes, these BodyFIX® 14 Localizer Fiducial Set Aluminium contrast rods allow improved visualization in CT.
2016-08-23