# K111106: Truebeam

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 18, 2011 after 120 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: 6 generations back to K926449 (1995). 26 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092871: Trilogy MX, Varian Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K143224: TrueBeam-TrueBeam STx-Edge (2014), 25 descendants of its own
- K162472: TrueBeam-TrueBeam STx-Edge (2017), 23 descendants of its own

## Recalls of this device
- Apr 9, 2012 · Not classified · Z-1495-2012: A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.
- Apr 9, 2012 · Not classified · Z-1617-2012: Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the op
- Jan 30, 2012 · Not classified · Z-1175-2012: An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retainin
- 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
- Oct 31, 2011 · Not classified · Z-0364-2012: An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.

## 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/K111106
Methodology: https://510kreport.com/methodology