# K021268: Eclipse, Helios Option

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 22, 2002 after 30 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
No predicates in its family tree.
103 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K9845432: CadPlan Helios Option Version 6.0. Number could not be read Summary page 1.

## Most influential descendants
- K050296: Eclipse Treatment Planning System (2005), 101 descendants of its own
- K071873: Modification to Eclipse Treatment Planning System (2007), 94 descendants of its own
- K073020: Eclipse Treatment Planning System (2007), 92 descendants of its own
- K091492: Modification to Eclipse Treatment Planning System (2009), 87 descendants of its own
- K102011: Eclipse Treatment Planning System (2010), 58 descendants of its own

## Indications for use
The Varian Eclipse Helios Option software is used to inversely plan photon radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 - 50 MV.

Source page: https://510kreport.com/device/K021268
Methodology: https://510kreport.com/methodology