# K061140: Trilogy Radiotherapy Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: May 15, 2006 after 21 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: 2 generations back to K913119 (1991). 4 ancestors in all.
86 later devices descend from it; 3 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033343: Trilogy Radiotherapy Delivery System, Varian Medical Systems, Inc. (2003) Summary page 1.
- K041315: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy, Accuray, Inc. (2004) Summary page 1.

## Most influential descendants
- K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System (2007), 78 descendants of its own
- K072916: Trilogy System with Rapidarc (2007), 77 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own

## Indications for use
The Trilogy TM Radiotherapy Delivery System and Trilogy Tx Delivery System are indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K061140
Methodology: https://510kreport.com/methodology