# K071873: Modification to Eclipse Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 9, 2007 after 34 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: 4 generations back to K010975 (2001). 8 ancestors in all.
94 later devices descend from it; 2 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050296: Eclipse Treatment Planning System, Varian Medical Systems (2005) Summary page 1.

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

## Recalls of this device
- May 13, 2010 · Not classified · Z-0455-2011: Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneous
- Jul 17, 2009 · Not classified · Z-2231-2009: Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
- Oct 2, 2008 · Not classified · Z-0855-2009: When using the multiple static segment option, the device may alter dose delivery.
- Feb 13, 2008 · Not classified · Z-1612-2008: A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
- Aug 17, 10 · Not classified · Z-0911-2011: Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though chan

## 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/K071873
Methodology: https://510kreport.com/methodology