# K041403: Eclipse with Aaa

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Jul 26, 2004 after 61 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: 2 generations back to K010975 (2001). 2 ancestors in all.
102 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030981: Eclipse, Varian Medical Systems, Inc. (2003) 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 device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1-50 MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators. Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review.

Source page: https://510kreport.com/device/K041403
Methodology: https://510kreport.com/methodology