# K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Feb 9, 2007 after 30 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: 3 generations back to K913119 (1991). 5 ancestors in all.
78 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061140: Trilogy Radiotherapy Delivery System, Varian Medical Systems (2006) Summary page 1.
- K033343: Trilogy Radiotherapy Delivery System, Varian Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K123808: Agility (2013), 36 descendants of its own

## Recalls of this device
- Jun 23, 2010 · Not classified · Z-1249-2011: Position errors may result in misdelivery of radiation.
- Jun 10, 2010 · Not classified · Z-0886-2011: The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with 
- Oct 8, 2009 · Not classified · Z-0910-2011: Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
- Sep 10, 2007 · Not classified · Z-0545-2008: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator an
- Sep 10, 2007 · Not classified · Z-0544-2008: Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wr

## Indications for use
The Trilogy Tm 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/K070094
Methodology: https://510kreport.com/methodology