# K081188: Trilogy with External System Gating Interface

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 14, 2008 after 77 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913119 (1991). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 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.

## Most influential descendants
- K100890: Varian High Energy Linear Accelerator (2010), 4 descendants of its own
- K112839: Varian High Energy Linear Accelerator (2011), 3 descendants of its own
- K131807: High Energy Linear Accelerator (2013), 2 descendants of its own
- K162476: Varian High Energy Linear Accelerator (2016), 1 descendant of its own
- K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (2018), 0 descendants of its own

## Recalls of this device
- Aug 14, 2012 · Class II · Z-2383-2012: Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move 

## Indications for use
The Trilogy Tm Radiotherapy Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The External System Gating Interface is indicated for use in exporting beam information to external gating devices.

Source page: https://510kreport.com/device/K081188
Methodology: https://510kreport.com/methodology