# K203766: 4D Integrated Treatment Console

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Feb 12, 2021 after 51 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001643 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133331: 4D Integrated Treatment Console, Varian Medical Systems, Inc. (2014) Summary page 4.

## 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/K203766
Methodology: https://510kreport.com/methodology