# K091492: Modification to Eclipse Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 18, 2009 after 29 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010975 (2001). 10 ancestors in all.
87 later devices descend from it; 4 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073020: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K152393: Eclipse Treatment Planning System (2015), 33 descendants of its own

## Recalls of this device
- Oct 31, 2011 · Not classified · Z-0370-2012: An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclip
- Aug 11, 2010 · Not classified · Z-3103-2011: Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient 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/K091492
Methodology: https://510kreport.com/methodology