Address:Robert-Bosch-Strasse 8,SCHWABMUENCHEN Bavaria,DE
Device Description : The Fraxion FRAXION™ Preparation Kit includes individual patient storage boxes a The Fraxion FRAXION™ Preparation Kit includes individual patient storage boxes and all necessary components to prepare the individual patient set-up together with the FRAXION™ Mouthpiece Kit and the FRAXION™ Dental Kit.
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : HexaPOD Handheld Controller for manual movement of HexaPOD evo module
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : iGUIDE Reference Frame Set used by iGUIDE Software to control position of HexaPOD evo
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : HexaPOD™ Enable Switch Board enables the HexaPOD™ evo Module to execute a movement command
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour positio HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO center
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : iGUIDE® Software 2.2 is the software which controls the movement of the the Hex 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
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : HexaPOD™ evo PowerBox supplies the electrical power and interfaces between the components
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold BodyFIX® Hygienic Drape Manifold Tube (2x15000mm) is used to cover the manifold tube for hygienic purposes.
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : BodyFIX® Hygienic Drape Manifold Cushion (2x15000mm) is used to cover the vacuum BodyFIX® Hygienic Drape Manifold Cushion (2x15000mm) is used to cover the vacuum manifold cushion for hygienic purposes.
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes
Device Description : iGUIDE® Software 2.2.1 is the software which controls the movement of the HexaPO 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.
Device Class : 2
Duns Number: 314546664
Premarket Exempt : No
Prescription Use : Yes