# K180586: Varian Head Frame

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 2, 2018 after 28 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 K971675 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142560: Varian Head Frame, Varian Medical Systems, Inc. (2014) Summary page 4.

## Indications for use
The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

Source page: https://510kreport.com/device/K180586
Methodology: https://510kreport.com/methodology