# K050479: 4D Integrated Treatment Console

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Mar 24, 2005 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001643 (2000). 1 ancestor in all.
72 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001643: Varis 1.4G, Varian Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs) (2008), 69 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own
- K123808: Agility (2013), 36 descendants of its own

## Recalls of this device
- Sep 21, 2006 · Not classified · Z-0304-2007: Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
- Sep 20, 2005 · Not classified · Z-1375-06: A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear

## Indications for use
The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

Source page: https://510kreport.com/device/K050479
Methodology: https://510kreport.com/methodology