# K260750: Virtual Cone (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 8, 2026 after 124 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 19 generations back to K010975 (2001). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242378: Eclipse Treatment Planning System (18.1), Varian Medical Systems (2024) Summary page 5.

## Indications for use
The Virtual Cone plan insertion tool is an ESAPI script intended to facilitate the noninvasive treatment of small, spherical intracranial targets by automating part of the planning process within the Eclipse Treatment Planning System. It enables the generation, by clinical users, of precise, conformal dose distributions comparable to those achieved with physical stereotactic cones, streamlining the treatment planning and delivery process. To achieve this, the script automates the creation of a fixed, small MLC-defined aperture by generating a standardized control point sequence with sinusoidal dose rate modulation.

Source page: https://510kreport.com/device/K260750
Methodology: https://510kreport.com/methodology