510(k) · Cleared
Recalled · 2010Modification 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 Aug 9, 2007 as substantially equivalent to K050296 (Varian Medical Systems, 2005) after a 34-day review. Its family tree reaches back 4 generations to 2001. 94 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 9, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010975 (2001). 8 ancestors in all, the oldest K992762 (2000). 94 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 2 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 1 generation backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- This deviceK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007
- Descendant · cites it directly · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 58 of its ownK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 37 of its ownK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- Descendant · 5 generations on · 36 of its ownK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · cites it directly92descendants
- K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 2 generations on87descendants
- K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · 3 generations on58descendants
- K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013 · 4 generations on37descendants
- K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −3 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −2 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −1 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| 0 (this device) | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | — |
| +1 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| +2 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| +3 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| +4 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| +5 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 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 |
|---|---|---|---|
| * | K050296 | Eclipse Treatment Planning SystemSummary page 1…apy system, 21 CFR 892.5050, MUJ, CInsi Common/Usual Name: Eclipse TPS Predicate Devices: Eclipse Treatment Planning System, K050296 Device Description: The Varian EclipseTM Treatment Planning System (Eclipse TPS) (K050296) pro… | 2005 |
What descends from it? (94)
See all 942 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 |
|---|---|---|---|---|
| May 13, 2010 | Not classified | Z-0455-2011 | Software design | 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 simultaneously can result in a corrupted (but… |
| Jul 17, 2009 | Not classified | Z-2231-2009 | Software design | 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 | Software design | When using the multiple static segment option, the device may alter dose delivery. |
| Feb 13, 2008 | Not classified | Z-1612-2008 | Software design | A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. |
| Aug 17, 10 | Not classified | Z-0911-2011 | Software design | 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 changes have been made which affect dose. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K073020 (Varian Medical Systems, Inc., 2007) has gone furthest, with 92 descendants of its own.
- 1 other device also cites its predicate K050296.
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. 2007, 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/K071873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071873: Modification to 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/K071873
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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