# K101751: Varian Unique Single Energy Linear Accelerator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Oncology Systems
- Decided: Aug 10, 2010 after 49 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: 5 generations back to K913119 (1991). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072916: Trilogy System with Rapidarc, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K132705: Unique (2013), 1 descendant of its own
- K232489: VenusX (2024), 0 descendants 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-0483-2012: 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 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/K101751
Methodology: https://510kreport.com/methodology