# K964138: Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jan 10, 1997 after 87 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853349 (1985). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K853349: Varian Ximatron C-Series Radiotherapy Treatment ST, Varian Assoc., Inc. (1985) Summary page 1.

## Most influential descendants
- K023052: Acuity Radiation Therapy Simulator (2002), 1 descendant of its own
- K033339: Acuity with Conebeam Computed Tomography (2003), 0 descendants of its own

## Recalls of this device
- Jan 19, 2010 · Not classified · Z-0892-2011: There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.

## Indications for use
The Ximatron Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.

Source page: https://510kreport.com/device/K964138
Methodology: https://510kreport.com/methodology