# K123291: Truebeam

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 20, 2012 after 59 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 7 generations back to K926449 (1995). 27 ancestors in all.
37 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111106: Truebeam, Varian Medical Systems, Inc. (2011) Summary page 1.

## Most influential descendants
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own
- K143224: TrueBeam-TrueBeam STx-Edge (2014), 25 descendants of its own
- K162472: TrueBeam-TrueBeam STx-Edge (2017), 23 descendants of its own
- K170817: Halcyon (2017), 15 descendants of its own
- K181032: Halcyon (2018), 14 descendants of its own

## Indications for use
TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K123291
Methodology: https://510kreport.com/methodology