# K052361: Simulix-Evolution with Oncentra Conebeam

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: Oct 24, 2005 after 56 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: 2 generations back to K946128 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033470: Simulix Evolution, Nucletron Corporation (2004) Summary page 1.
- K932848: Simulix-MC CT Extension, Oldelft Corp. of America (1994) Summary page 2.

## Indications for use
Simulix Evolution is a radiation therapy simulation system 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. The Oncentra Cone Beam CT option for the Simulix Evolution Radiation Therapy Simulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning

Source page: https://510kreport.com/device/K052361
Methodology: https://510kreport.com/methodology