# K091132: 4D Integrated Treatment Console

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Jun 17, 2009 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001643 (2000). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 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.
- K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs), Varian Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K133331: 4D Integrated Treatment Console (2014), 1 descendant of its own
- K122616: Panther Ois/R & V Model Version 2.0 (2012), 1 descendant of its own
- K211760: Panther OIS (2021), 0 descendants of its own
- K203766: 4D Integrated Treatment Console (2021), 0 descendants of its own
- K142268: Varian Verification System (VVS) (2014), 0 descendants of its own

## Recalls of this device
- Dec 12, 2011 · Not classified · Z-0691-2012: Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO
- Dec 12, 2011 · Not classified · Z-0715-2012: When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, 
- Jul 21, 2011 · Not classified · Z-3194-2011: The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information syst
- Feb 28, 2011 · Not classified · Z-2119-2011: A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.
- Oct 16, 2009 · Not classified · Z-0891-2011: Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.

## 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/K091132
Methodology: https://510kreport.com/methodology