GAMMEX, INC.

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- Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805659

Device Description : The CT Sim+, 5-Arm, Blue Laser is used in the simulation stage of radiation ther The CT Sim+, 5-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 : 805658

Device Description : The CT Sim+, 5-Arm, Green Laser is used in the simulation stage of radiation the The CT Sim+, 5-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 : 805655

Device Description : The CT Sim+, 5-Arm, Red Laser is used in the simulation stage of radiation thera The CT Sim+, 5-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 :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Gammex CT Sim Laser systems are used in the simulation stage of radiation therap Gammex CT Sim Laser systems are 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 specified file 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 :

Device Description : Gammex CT Sim Laser systems are used in the simulation stage of radiation therap Gammex CT Sim Laser systems are 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 specified file 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 :

Device Description : Gammex CT Sim Laser systems are used in the simulation stage of radiation therap Gammex CT Sim Laser systems are 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 specified file 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 :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : No

Product Code : IWE

Prescription Use : Yes

Device Count : 1