# K142243: LessRay with Tracking

- Pathway: 510(k) (Traditional)
- Applicant: Saferay Spine, LLC
- Decided: Nov 18, 2014 after 97 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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
Longest line of descent: 3 generations back to K013841 (2002). 3 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132970: Lessray, Saferay Spine, LLC (2013) Summary page 4.
- K123226: Lessray, Saferay Spine, LLC (2012) Summary page 5.

## Most influential descendants
- K170800: NuVasive LessRay with Enhanced Tracking (2017), 12 descendants of its own
- K173314: LessRay System (2017), 4 descendants of its own
- K180038: NuVasive Pulse System (2018), 3 descendants of its own
- K173736: TrackX (2018), 3 descendants of its own
- K210574: NuVasive Pulse System (2021), 2 descendants of its own

## Indications for use
LessRay® with Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Source page: https://510kreport.com/device/K142243
Methodology: https://510kreport.com/methodology