# K092871: Trilogy MX

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 30, 2009 after 73 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: 5 generations back to K926449 (1995). 25 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072916: Trilogy System with Rapidarc, Varian Medical Systems, Inc. (2007) Summary page 1.
- K042720: ON-Board Imager Device, Varian Medical Systems (2004) Summary page 1.
- K063270: RPM Respiratory Gating System, Varian Medical Systems, Inc. (2006) Summary page 1.
- K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs), Varian Medical Systems, Inc. (2008) Summary page 1.
- K003636: Portalvision, Varian Medical Systems, Inc. (2001) Summary page 1.
- K071992: High-Definition 120 Multileaf Collimator (HD120 MLC), Varian Medical Systems (2007) Summary page 1.
- K050442: Millennium Multi-Leaf Collimator, Varian Medical Systems (2005) Summary page 1.

## Most influential descendants
- K111106: Truebeam (2011), 43 descendants of its own
- 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

## Recalls of this device
- Jun 21, 2011 · Not classified · Z-3101-2011: Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.
- May 19, 2011 · Not classified · Z-2766-2011: Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
- Apr 5, 2011 · Not classified · Z-2181-2011: Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops track
- May 24, 2010 · Not classified · Z-0106-2011: Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual pat
- Dec 1, 2009 · Not classified · Z-1001-2011: A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.

## Indications for use
Trilogy Mx 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/K092871
Methodology: https://510kreport.com/methodology