# K010975: Eclipse 6.5

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 2, 2001 after 30 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
108 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030981: Eclipse (2003), 107 descendants of its own
- K041403: Eclipse with Aaa (2004), 102 descendants of its own
- K050296: Eclipse Treatment Planning System (2005), 101 descendants of its own
- K071873: Modification to Eclipse Treatment Planning System (2007), 94 descendants of its own
- K073020: Eclipse Treatment Planning System (2007), 92 descendants of its own

## Recalls of this device
- Nov 21, 2008 · Not classified · Z-0861-2009: Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and
- Jun 11, 2008 · Not classified · Z-2308-2008: Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.
- Nov 23, 2005 · Not classified · Z-0393-06: The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

Source page: https://510kreport.com/device/K010975
Methodology: https://510kreport.com/methodology