CT Sim

GUDID B136A5000A0

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.

GAMMEX, INC.

Laser patient positioning system

• Primary Device ID: B136A5000A0
• NIH Device Record Key: 05250d52-9b1c-4f30-a681-b9ecb4947a8f
• Commercial Distribution Discontinuation: 2017-05-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CT Sim
• Version Model Number: 805142
• Company DUNS: 157308230
• Company Name: GAMMEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004266391
• Email: sales@gammex.com
• Phone: +18004266391
• Email: sales@gammex.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B136A5000A0 [Primary]

FDA Product Code

• IWE: Monitor, Patient Position, Light-Beam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-26
• Device Publish Date: 2016-09-23

On-Brand Devices [CT Sim]

• B136A5000A0: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
• B136A4110G0: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
• B136A4100G0: 805044
• B136A4010A0: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
• B136A3100G0: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p
• B136A3000A0: Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a p