# K152303: CT Sim Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Gammex, Inc.
- Decided: Sep 11, 2015 after 28 days
- Product code: IWE (Monitor, Patient Position, Light-Beam)
- Device class: 1
- Regulation: 21 CFR 892.5780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933431 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943381: Laser Alignment Tool, Philips Medical Systems North America, Inc. (1994) Summary page 5.
- K872489: Centralite, Diacor, Inc. (1987) Summary page 5.

## Indications for use
The CT Sim Laser System 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 isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.

Source page: https://510kreport.com/device/K152303
Methodology: https://510kreport.com/methodology