AccessGUDID - DEVICE: CT Sim (B136A5000A0)

GUDID

Device Identifier (DI) Information

Brand Name: CT Sim
Version or Model: 805142
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B136A5000A0
Issuing Agency: HIBCC
Commercial Distribution End Date: May 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40893	Laser patient positioning system	A fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWE	Monitor, Patient Position, Light-Beam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05250d52-9b1c-4f30-a681-b9ecb4947a8f
Public Version Date: January 09, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016