GAMMEX, INC.

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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 : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805710

Device Description : The MICRO MLB 150 lasers are intended to be used for aligning patients to medica The MICRO MLB 150 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805709

Device Description : The MICRO MLB 200 lasers are intended to be used for aligning patients to medica The MICRO MLB 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Device Description : The MICRO+ MLG+300 Laser is used for aligning patients to medical diagnostic ima The MICRO+ MLG+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805727

Device Description : The MICRO+ MLB+350 Laser is used for aligning patients to medical diagnostic ima The MICRO+ MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Device Description : The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 805708

Device Description : The MICRO MLG 150 lasers are intended to be used for aligning patients to medica The MICRO MLG 150 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1