# K933431: Orthotrac Coaxial Laser

- Pathway: 510(k) (Traditional)
- Applicant: Trac Medical, Inc.
- Decided: Oct 5, 1993 after 83 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) OEC-Diasonics Laser Aiming Device: named in the summary without a submission number

## Most influential descendants
- K943381: Laser Alignment Tool (1994), 1 descendant of its own
- K152303: CT Sim Laser System (2015), 0 descendants of its own

## Indications for use
The Orthotrac Coaxial Laser is an optional accessory designed for use with any currently marketed Mobile C-Arm unit. It does not alter the intended use of the basic C-Arm unit for routine diagnostic imaging.

Source page: https://510kreport.com/device/K933431
Methodology: https://510kreport.com/methodology