CT Sim - Gammex CT Sim Laser systems are used in the - GAMMEX, INC.

Duns Number:157308230

Device Description: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepa 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.

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More Product Details

Catalog Number

-

Brand Name

CT Sim

Version/Model Number

805043

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2017

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IWE

Product Code Name

Monitor, Patient Position, Light-Beam

Device Record Status

Public Device Record Key

652aacdc-f932-493c-b74c-3f7a5ec71199

Public Version Date

September 26, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GAMMEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72