CT Sim+ 805759

GUDID B1361000BRC0

The CT Sim+, 1-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.

GAMMEX, INC.

Laser patient positioning system Laser patient positioning system

• Primary Device ID: B1361000BRC0
• NIH Device Record Key: b8bd525c-d1c6-4b7c-8f44-6e730cffe37e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT Sim+
• Version Model Number: CT Sim+
• Catalog Number: 805759
• 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: servicedepartment@gammex.com
• Phone: +18004266391
• Email: servicedepartment@gammex.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1361000BRC0 [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: 2019-10-02
• Device Publish Date: 2017-08-14

On-Brand Devices [CT Sim+]

• B1365000R0: The CT Sim+, 5-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a
• B1365000G0: The CT Sim+, 5-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare
• B1365000B0: The CT Sim+, 5-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a
• B1363000R0: The CT Sim+, 3-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a
• B1363000G0: The CT Sim+, 3-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare
• B1363000B0: The CT Sim+, 3-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a
• B1361000RRC0: The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a
• B1361000R0: The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a
• B1361000GRC0: The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare
• B1361000G0: The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare
• B1361000BRC0: The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a
• B1361000B0: The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a