# K050296: Eclipse Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Nov 3, 2005 after 269 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: 3 generations back to K010975 (2001). 7 ancestors in all.
101 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)
- K041403: Eclipse with Aaa, Varian Medical Systems (2004) Summary page 1.
- K021268: Eclipse, Helios Option, Varian Medical Systems, Inc. (2002) Summary page 1.
- K002312: Proton Vision 7.0, Varian Medical Systems, Inc. (2000) Summary page 1.
- K992762: Brachyvision 6.0, Varian Assoc., Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K131891: Eclipse Treatment Planning System (2013), 37 descendants of its own

## Indications for use
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Source page: https://510kreport.com/device/K050296
Methodology: https://510kreport.com/methodology