# K102011: Eclipse Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Sep 3, 2010 after 49 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010975 (2001). 11 ancestors in all.
58 later devices descend from it; 5 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091492: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K131891: Eclipse Treatment Planning System (2013), 37 descendants of its own
- K133247: Eclipse Treatment Planning System (2014), 36 descendants of its own
- K141283: Eclipse Treatment Planning System (2014), 35 descendants of its own
- K152393: Eclipse Treatment Planning System (2015), 33 descendants of its own
- K170969: Eclipse Treatment Planning System (2017), 30 descendants of its own

## Recalls of this device
- Jan 28, 2013 · Class II · Z-0867-2013: The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
- Aug 17, 2012 · Class II · Z-2462-2012: Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Worksta
- Jan 30, 2012 · Not classified · Z-1161-2012: Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while 
- Dec 12, 2011 · Not classified · Z-0736-2012: An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and the
- May 20, 2011 · Not classified · Z-2788-2011: A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.

## 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/K102011
Methodology: https://510kreport.com/methodology