# K062618: Trilogy TX with 3RD Party Couch Top Support

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Sep 22, 2006 after 17 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: 3 generations back to K913119 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.

## Indications for use
The Trilogy Tx 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 3 d Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.

Source page: https://510kreport.com/device/K062618
Methodology: https://510kreport.com/methodology