# K033343: Trilogy Radiotherapy Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 23, 2003 after 67 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913119 (1991). 2 ancestors in all.
87 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913119: Varian C-Series Clinacs (Clinac 2300C/D), Varian Assoc., Inc. (1991) Summary page 1.
- K002509: Novalis (Shaped Beam Surgery System), Brainlab AG (2000) Summary page 1.

## Most influential descendants
- K061140: Trilogy Radiotherapy Delivery System (2006), 86 descendants of its own
- 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

## Recalls of this device
- Sep 9, 2011 · Not classified · Z-0181-2012: Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automate mode.
- May 26, 2011 · Not classified · Z-2978-2011: On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.
- May 13, 2011 · Not classified · Z-2778-2011: Some drive stand bolts may fail to meet mechanical specifications.

## Indications for use
The Trilogy TM Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

Source page: https://510kreport.com/device/K033343
Methodology: https://510kreport.com/methodology