510(k) · Cleared
Recalled · Class II · 2018Eclipse 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 May 18, 2018 as substantially equivalent to K172163 (Varian Medical Systems, Inc., 2017) after a 17-day review. Its family tree reaches back 14 generations to 2001. 26 later devices descend from it. It has been recalled once.
- Decided
- May 18, 2018
- Review
- 17 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K010975 (2001). 18 ancestors in all, the oldest K992762 (2000). 26 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 10 generations between
- 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- This deviceK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK192377 Ethos Treatment Management, Ethos Treatment Planning, Ethos…Varian Medical Systems, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · cites it directly · 5 of its ownK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 2 generations on · 4 of its ownK212294 Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021
Show all 14 generations
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 13 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 12 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 11 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 10 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 8 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 6 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 5 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 4 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 2 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- This deviceK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · 2020 · cites it directly9descendants
- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · cites it directly5descendants
- K200608Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020 · cites it directly5descendants
- K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 2 generations on4descendants
- K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −13 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −12 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −11 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −10 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −9 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −8 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −7 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −6 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −5 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −4 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −3 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −2 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −1 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| 0 (this device) | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy… | Varian Medical Systems, Inc. | 2020 | — |
| +1 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +1 | K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | 2020 | — |
| +2 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | 8 |
| +2 | K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | 2021 | — |
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 |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K172163 | Eclipse Treatment Planning SystemSummary page 4…Regulatory Class: II Product Code: MUJ III. PREDICATE DEVICE Eclipse Treatment Planning System, K172163 IV. DEVICE DESCRIPTION The Varian Eclipse™ Treatment Planning System (Eclipse TPS)… | 2017 |
What descends from it? (26)
See all 265 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | 2020 | 9 |
| K210645 | RayStation 10.1 | 2021 | 5 |
| K200608 | Eclipse Treatment Planning System v16.0 | 2020 | 5 |
| K222728 | Radiation Planning Assistant (RPA) | 2023 | 2 |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2018 | Class II | Z-0771-2019 | Software design | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 18 ancestors have a recall of any class.
- Of its descendants, K192377 (Varian Medical Systems, Inc., 2020) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K172163.
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. 2018, 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/K181145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181145: 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/K181145
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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