# K072916: Trilogy System with Rapidarc

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 9, 2007 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913119 (1991). 6 ancestors in all.
77 later devices descend from it; 6 cite 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)
- K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K140528: True Beam, True Beam STX, Edge (2014), 31 descendants of its own

## Recalls of this device
- Jul 20, 2010 · Not classified · Z-0821-2011: The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as D
- 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
The Trilogy Tm System with RapidArc is 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/K072916
Methodology: https://510kreport.com/methodology