# K093967: Varian Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 12, 2010 after 201 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 2 generations back to K001643 (2000). 2 ancestors in all.
1 later device descends 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)
- K050479: 4D Integrated Treatment Console, Varian Medical Systems (2005) Summary page 1.

## Most influential descendants
- K151882: Varian Treatment  (VTx) (2015), 0 descendants of its own

## Recalls of this device
- Jul 20, 2011 · Not classified · Z-3105-2011: Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned w

## Indications for use
Varian Treatment provides accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device from commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

Source page: https://510kreport.com/device/K093967
Methodology: https://510kreport.com/methodology