510(k) · Cleared
Recalled · 2011Modification to Eclipse 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 Jun 18, 2009 as substantially equivalent to K073020 (Varian Medical Systems, Inc., 2007) after a 29-day review. Its family tree reaches back 6 generations to 2001. 87 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 18, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010975 (2001). 10 ancestors in all, the oldest K992762 (2000). 87 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 4 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 3 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 2 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- This deviceK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009
- Descendant · cites it directly · 58 of its ownK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 37 of its ownK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 36 of its ownK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- Descendant · 3 generations on · 35 of its ownK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 33 of its ownK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · cites it directly58descendants
- K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013 · 2 generations on37descendants
- K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · 3 generations on36descendants
- K141283Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · 3 generations on35descendants
- K152393Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −5 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −4 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −3 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −2 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −1 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| 0 (this device) | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | — |
| +1 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| +2 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| +3 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| +3 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| +4 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 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 |
|---|---|---|---|
| * | K073020 | Eclipse Treatment Planning SystemSummary page 1…ation therapy system, 21 CFR §892.5050, MUJ ClIIS§§ Common/Usual Name: Eclipse TPS Predicate Devices: Eclipse Treatment Planning System, K073020 Device Description: The Varian Eclipselm Treatment Planning System (Eclipse TPS) provides software too… | 2007 |
What descends from it? (87)
See all 874 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 |
|---|---|---|---|---|
| Oct 31, 2011 | Not classified | Z-0370-2012 | Device Design | 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 Eclipse. |
| Aug 11, 2010 | Not classified | Z-3103-2011 | Software design | Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K102011 (Varian Medical Systems, Inc., 2010) has gone furthest, with 58 descendants of its own.
- 1 other device also cites its predicate K073020.
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. 2009, 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/K091492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091492: Modification to Eclipse Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091492
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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