Medical Intelligence Medizintechnik GmbH

Address:Robert-Bosch-Strasse 8,SCHWABMUENCHEN Bavaria,DE

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- Catalog Number : P10106-603

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10602-107

Device Description : HexaPOD Handheld Controller for manual movement of HexaPOD evo module

Device Class : 2

Duns Number: 314546664

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10602-131

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10602-132

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

Product Code : JAI

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10603-100

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

Product Code : JAI

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10603-109

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10603-142

Device Description : HexaPOD™ evo PowerBox supplies the electrical power and interfaces between the components

Device Class : 2

Duns Number: 314546664

Premarket Exempt : No

Product Code : JAI

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10102-305

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10102-309

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : P10603-110

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

Product Code : IYE

Prescription Use : Yes

Device Count : 1