# K030981: Eclipse

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 24, 2003 after 88 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010975 (2001). 1 ancestor in all.
107 later devices descend from it; 2 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010975: Eclipse 6.5, Varian Medical Systems, Inc. (2001)

## Most influential descendants
- K041403: Eclipse with Aaa (2004), 102 descendants of its own
- 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

## Indications for use
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar radiotherapy devices with x- ray energies from 1 -50MV, as well as Cobalt-60 and electron energies from 1 - 50MeV. 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 includes also tools for treatment preparation (diagnostic image analysis, contouring and segmentation) and plan review. As part of the VARIS Vision System, Eclipse integrates the treatment planning in overall therapy process, while taking advantage of the Varian Vision database.

Source page: https://510kreport.com/device/K030981
Methodology: https://510kreport.com/methodology