# K980629: VSS, Virtual Simulation System

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: May 6, 1998 after 77 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914926 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.
- K951830: Advantage Sim, General Electric Co. (1995) Summary page 1.
- K964206: Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2, Nucletron Corp. (1997) Summary page 1.

## Indications for use
Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation. When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.

Source page: https://510kreport.com/device/K980629
Methodology: https://510kreport.com/methodology