# K112839: Varian High Energy Linear Accelerator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Nov 14, 2011 after 47 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: 7 generations back to K913119 (1991). 9 ancestors in all.
3 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)
- K100890: Varian High Energy Linear Accelerator, Varian Medical Systems (2010) Summary page 1.

## Most influential descendants
- 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
- Nov 28, 2011 · Not classified · Z-0692-2012: An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.

## Indications for use
The Varian High Energy Linear Accelerator 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/K112839
Methodology: https://510kreport.com/methodology