# K132705: Unique

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 31, 2013 after 63 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: 6 generations back to K913119 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101751: Varian Unique Single Energy Linear Accelerator, Varian Medical Systems, Oncology Systems (2010) Summary page 1.

## Most influential descendants
- K181404: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (2018), 0 descendants of its own

## Recalls of this device
- 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 UNIQUE 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/K132705
Methodology: https://510kreport.com/methodology