# K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs)

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 9, 2008 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (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.
69 later devices descend from it; 3 cite it directly.
0 of 72 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
- 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
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own

## Recalls of this device
- Jun 27, 2011 · Not classified · Z-3100-2011: In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal 
- Jun 23, 2011 · Not classified · Z-3098-2011: Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history informatio
- Dec 14, 2010 · Not classified · Z-0932-2011: Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present.

## Indications for use
The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

Source page: https://510kreport.com/device/K081036
Methodology: https://510kreport.com/methodology