GAMMEX, INC.

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- Catalog Number : 805656

Device Description : The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation ther The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805759

Device Description : The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation ther The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805654

Device Description : The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation the The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805758

Device Description : The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation the The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805653

Device Description : The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation thera The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805757

Device Description : The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation thera The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1