510(k) · Cleared
ClearedEclipse Treatment Planning System v16.1
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 Jul 10, 2020 as substantially equivalent to K200608 (Varian Medical Systems, Inc., 2020) after a 25-day review. Its family tree reaches back 16 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 10, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K010975 (2001). 20 ancestors in all, the oldest K992762 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 12 generations between
- 3 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- 1 generation backK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- This deviceK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK230557 Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK242378 Eclipse Treatment Planning System (18.1)Varian Medical Systems · 2024
- Descendant · 3 generations on · 0 of its ownK260750 Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250963 PlanOne 1Cosylab Jsc, Control System Laboratory · 2025
Show all 16 generations
- Root · 16 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 15 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 14 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 13 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 12 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 11 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 10 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 9 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 8 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 7 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 6 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 5 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 4 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 3 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- 1 generation backK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- This deviceK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K230557Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023 · cites it directly3descendants
- K242378Eclipse Treatment Planning System (18.1)Varian Medical Systems · 2024 · 2 generations on1descendant
- K260750Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026 · 3 generations on0descendants
- K250963PlanOne 1Cosylab Jsc, Control System Laboratory · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −15 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −14 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −13 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −12 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −11 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −10 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −9 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −8 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −7 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −6 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −5 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −4 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −3 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −2 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| −1 | K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | 2020 | — |
| 0 (this device) | K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | 2020 | — |
| +1 | K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023 | — |
| +2 | K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024 | — |
| +3 | K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | 2026 | — |
| +2 | K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K200608 | Eclipse Treatment Planning System v16.0Summary page 4…MUJ | 21 CFR 892.5050 | Class II PREDICATE DEVICE Predicate Device Name: Eclipse Treatment Planning System v16.0 (K200608) Reference Device(s): No reference devices were used in this submission. DEVICE DESCRIPTION The Varian Ec… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230557 | Eclipse Treatment Planning System (v18.0) | 2023 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K230557 (Varian Medical Systems, Inc., 2023) has gone furthest, with 3 descendants of its own.
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. 2020, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201607: Eclipse Treatment Planning System v16.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201607
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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