# K013841: 3DFIS, Model Ies-FL-101

- Pathway: 510(k) (Traditional)
- Applicant: 3Dsharp, Inc.
- Decided: Jan 17, 2002 after 58 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123226: Lessray (2012), 15 descendants of its own
- 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

## Indications for use
The 3DFIS 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/K013841
Methodology: https://510kreport.com/methodology