# K943381: Laser Alignment Tool

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Aug 9, 1994 after 27 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: 1 generation back to K933431 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933431: Orthotrac Coaxial Laser, Trac Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K152303: CT Sim Laser System (2015), 0 descendants of its own

## Indications for use
The laser alignment tool is used for patient positioning on our BV series Mobile Fluoroscopic X-Ray Systems. The current procedure is to use fluoroscopic x-ray exposure to correctly position the patient relative to the central x-ray beam. By providing a visible indicator of the central beam location, patient positioning is facilitated for the surgeon while x-ray dose is reduced for the patient. Clinical applications include situations in which the surgeon utilized the x-ray beam for alignment or guidance in a procedure The procedures themselves would not be altered with the exception of the use of the visible spectrum to indicate alignment rather than fluoroscopic shadows. The system consists of a HeNe laser device and an optical guide which allows the light to be emitted long the central axis of the x-ray beam. A means is provided to physically align the beam. The laser alignment tool is an accessory used to visualize the location of the central axis of the x-ray beam whether or not x-rays are energized. It has no clinical value beyond the surgeon's use of that visualization. It does not enable new treatments nor generate information which is not available through other means. The accuracy of the visualization is wholly demonstrable through the use of bench testing and specification.

Source page: https://510kreport.com/device/K943381
Methodology: https://510kreport.com/methodology