# K090706: Oncentra Simulation 2.3

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corporation
- Decided: Jun 15, 2009 after 90 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.
- K954055: HDX Digital Imaging System, Imacom, Inc. (1995) Summary page 1.

## Indications for use
Oncentra Simulation is an accessory to a radiation therapy simulation system which 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 their treatment.

Source page: https://510kreport.com/device/K090706
Methodology: https://510kreport.com/methodology