# K853349: Varian Ximatron C-Series Radiotherapy Treatment ST

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Oct 28, 1985 after 77 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
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964138: Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software (1997), 2 descendants of its own
- K023052: Acuity Radiation Therapy Simulator (2002), 1 descendant of its own
- K033339: Acuity with Conebeam Computed Tomography (2003), 0 descendants of its own
- K953233: Simview 3000 CT Option (1996), 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.

Source page: https://510kreport.com/device/K853349
Methodology: https://510kreport.com/methodology