# K123226: Lessray

- Pathway: 510(k) (Traditional)
- Applicant: Saferay Spine, LLC
- Decided: Dec 5, 2012 after 51 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: 1 generation back to K013841 (2002). 1 ancestor in all.
15 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)
- K013841: 3DFIS, Model Ies-FL-101, 3Dsharp, Inc. (2002) Summary page 1.

## Most influential descendants
- K132970: Lessray (2013), 14 descendants of its own
- K142243: LessRay with Tracking (2014), 13 descendants of its own
- 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

## Indications for use
The LessRay 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/K123226
Methodology: https://510kreport.com/methodology