# K133331: 4D Integrated Treatment Console

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jan 27, 2014 after 90 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 4 generations back to K001643 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091132: 4D Integrated Treatment Console, Varian Medical Systems (2009) Summary page 1.

## Most influential descendants
- K203766: 4D Integrated Treatment Console (2021), 0 descendants of its own

## Recalls of this device
- Aug 18, 2014 · Class II · Z-2654-2014: Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract consol

## Indications for use
The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by 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/K133331
Methodology: https://510kreport.com/methodology