# K131807: High Energy Linear Accelerator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 11, 2013 after 114 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: 8 generations back to K913119 (1991). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112839: Varian High Energy Linear Accelerator, Varian Medical Systems (2011) Summary page 1.

## Most influential descendants
- 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
- Nov 18, 2013 · Class II · Z-0552-2014: An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Moni
- Oct 24, 2013 · Class II · Z-0439-2014: This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.

## Indications for use
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors end conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K131807
Methodology: https://510kreport.com/methodology