Medical Intelligence Medizintechnik GmbH

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accelerator, Linear, Medical (IYE) (5) Table, radiographic, stationary top (IXQ) (3) Couch, Radiation Therapy, Powered (JAI) (1) Table, Radiographic, Stationary Top (IXQ) (1)

Premarket Exempt

No Yes

Clear

iGUIDE - 04056719002039 Catalog Number : P10603-111

Device Description : iGUIDE® Software 2.2.2 is the software which controls the movement of the the H 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

Device Class : 2

Duns Number: 314546664

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Fraxion™ - 04056719002060 Catalog Number :

Device Description : The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer.

Device Class :

Duns Number: 314546664

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

Fraxion™ - 04056719002077 Catalog Number :

Device Description : The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer.

Device Class :

Duns Number: 314546664

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

Fraxion™ - 04056719002084 Catalog Number :

Device Description : The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion H The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer.

Device Class :

Duns Number: 314546664

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

iGUIDE® - 04056719002190 Catalog Number : P10603-111

Device Description : iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Reviso iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.

Device Class : 2

Duns Number: 314546664

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

iBEAM® - 04056719002213 Catalog Number :

Device Description : iBEAM® one Couchtop is intended to support the patient during radiation therapy iBEAM® one Couchtop is intended to support the patient during radiation therapy or radiation therapy simulation.

Device Class : 2

Duns Number: 314546664

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : Yes

Device Count : 1

iBEAM® - 04056719002220 Catalog Number :

Device Description : iBEAM®evo CT Overlay Siemens Biograph

Device Class : 2

Duns Number: 314546664

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : Yes

Device Count : 1

iBEAM® - 04056719002237 Catalog Number :

Device Description : iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applications.

Device Class : 2

Duns Number: 314546664

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : Yes

Device Count : 1

HexaPOD - 04056719002244 Catalog Number : P10603-300

Device Description : HexaPOD one Module is a robotic couch top which fine adjusts the tumour position HexaPOD one 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

iBEAM - 04056719002251 Catalog Number : P10105-184

Device Description : iBEAM® evo Couchtop EH is intended to support the patient during radiation thera 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.

Device Class : 2

Duns Number: 314546664

Premarket Exempt : Yes

Product Code : IXQ

Prescription Use : Yes

Device Count : 1

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