510(k) · Cleared
Recalled · Class II · 2013Eclipse Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 3, 2010 as substantially equivalent to K091492 (Varian Medical Systems, Inc., 2009) after a 49-day review. Its family tree reaches back 7 generations to 2001. 58 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 3, 2010
- Review
- 49 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010975 (2001). 11 ancestors in all, the oldest K992762 (2000). 58 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 5 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 4 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 3 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010
- Descendant · cites it directly · 37 of its ownK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 36 of its ownK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 35 of its ownK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 33 of its ownK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 30 of its ownK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013 · cites it directly37descendants
- K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · 2 generations on36descendants
- K141283Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · 2 generations on35descendants
- K152393Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · 3 generations on33descendants
- K170969Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −6 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −4 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −3 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −1 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| 0 (this device) | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | — |
| +1 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| +2 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| +2 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| +3 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| +4 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091492 | Modification to Eclipse Treatment Planning SystemSummary page 1…therapy sy~stem, 21 CFR §892.5050, MUJ, Class II Common/Usual Name: Eclipse TPS Predicate Devices: Eclipse Treatment Planning System, K09 1492 Device Description: The Varian EclipseTm Treatment Planning System (Eclipse TPS) provides software t… | 2009 |
What descends from it? (58)
See all 585 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2013 | Class II | Z-0867-2013 | Software design | 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 | Software design | 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 Workstation is not synchronized with the… |
| Jan 30, 2012 | Not classified | Z-1161-2012 | Device Design | 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 the compensator or fluence editor is… |
| Dec 12, 2011 | Not classified | Z-0736-2012 | Software design | 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 then used as the beam limiting device for… |
| May 20, 2011 | Not classified | Z-2788-2011 | Software design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K131891 (Varian Medical Systems, Inc., 2013) has gone furthest, with 37 descendants of its own.
- 3 other devices also cite its predicate K091492.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102011: Eclipse Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102011
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026