# K052391: Vision (with Off-Line Review)

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Nov 23, 2005 after 84 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: 2 generations back to K952313 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042956: Vision, Varian Medical Systems, Inc. (2005) Summary page 1.

## Indications for use
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e. to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.

Source page: https://510kreport.com/device/K052391
Methodology: https://510kreport.com/methodology