# K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 28, 2018 after 30 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: 10 generations back to K913119 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162476: Varian High Energy Linear Accelerator, Varian Medical Systems, Inc. (2016) Summary page 4.
- K132705: Unique, Varian Medical Systems, Inc. (2013) Summary page 4.
- K133240: Varian Multileaf Collimator, Varian Medical Systems, Inc. (2014) Summary page 4.

## Recalls of this device
- Aug 12, 2019 · Class II · Z-1899-2020: After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient car

## 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. The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K181404
Methodology: https://510kreport.com/methodology