# K033470: Simulix Evolution

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: Feb 4, 2004 after 93 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- 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 K946128 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946128: Simulix-HP, Oldelft Corp. of America (1995) Summary page 1.

## Most influential descendants
- K090706: Oncentra Simulation 2.3 (2009), 0 descendants of its own
- K052361: Simulix-Evolution with Oncentra Conebeam (2005), 0 descendants of its own

## Indications for use
Simulix Evolution is a radiation therapy simulation system is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

Source page: https://510kreport.com/device/K033470
Methodology: https://510kreport.com/methodology