GAMMEX, INC.

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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

Instrument, Quality-Assurance, Radiologic (LHO) (8) Monitor, Patient Position, Light-Beam (IWE) (1) Phantom, Anthropomorphic, Radiographic (IXG) (1)

Premarket Exempt

No Yes

Clear

CT Sim+ - B1363000R0 Catalog Number : 805639

Device Description : The CT Sim+, 3-Arm, Red Laser is used in the simulation stage of radiation thera The CT Sim+, 3-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

Sun Nuclear Sono403 Multi-Purpose Phantom SCG - B136403GSLE0 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : IXG

Prescription Use : Yes

Device Count : 1

Sun Nuclear Tissue Mimicking Phantom - B136411LE0 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear SB3 Cortical Bone - B1364500 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CT Solid Water - B1364510 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear MS11 Muscle - B1364520 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear BR12 Breast - B1364530 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear BR12 Breast - B1364540 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear LN-300 Lung - B1364550 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear IB3 Inner Bone - B1364560 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

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