# K946128: Simulix-HP

- Pathway: 510(k) (Traditional)
- Applicant: Oldelft Corp. of America
- Decided: May 12, 1995 after 148 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033470: Simulix Evolution (2004), 2 descendants of its own
- K101038: Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager (2010), 0 descendants of its own
- K090706: Oncentra Simulation 2.3 (2009), 0 descendants of its own
- K052361: Simulix-Evolution with Oncentra Conebeam (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K946128
Methodology: https://510kreport.com/methodology