# K073020: Eclipse Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Dec 19, 2007 after 54 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010975 (2001). 9 ancestors in all.
92 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071873: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K133247: Eclipse Treatment Planning System (2014), 36 descendants of its own
- K141283: Eclipse Treatment Planning System (2014), 35 descendants of its own

## Recalls of this device
- Jul 7, 2011 · Not classified · Z-3022-2011: An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a
- Jun 30, 2011 · Not classified · Z-3002-2011: In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distr
- May 13, 2011 · Not classified · Z-2780-2011: In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.
- May 3, 2011 · Not classified · Z-2702-2011: In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose
- Apr 4, 2011 · Not classified · Z-2220-2011: An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.
- Dec 9, 2009 · Not classified · Z-1412-2010: Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.

## 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/K073020
Methodology: https://510kreport.com/methodology