510(k) · Cleared
ClearedEclipse with Aaa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 26, 2004 as substantially equivalent to K030981 (Varian Medical Systems, Inc., 2003) after a 61-day review. Its family tree reaches back 2 generations to 2001. 102 later devices descend from it.
- Decided
- Jul 26, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010975 (2001). 102 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK030981 EclipseVarian Medical Systems, Inc. · 2003
- This deviceK041403 Eclipse with AaaVarian Medical Systems · 2004
- Descendant · cites it directly · 101 of its ownK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- Descendant · 2 generations on · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 58 of its ownK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K050296Eclipse Treatment Planning SystemVarian Medical Systems · 2005 · cites it directly101descendants
- K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 2 generations on94descendants
- K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 3 generations on92descendants
- K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 4 generations on87descendants
- K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · 5 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −1 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| +1 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| +2 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| +3 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| +4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| +5 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 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 |
|---|---|---|---|
| * | K030981 | EclipseSummary page 1…Class II Product Code: 90 MUJ 3. Predicate Devices to claim substantial equivalence: a. Varian Eclipse, K030981 4. Description of the Device: The Varian Eclipse" Treatment Planning System has been modified to include a new a new ph… | 2003 |
What descends from it? (102)
See all 1021 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050296 | Eclipse Treatment Planning System | 2005 | 101 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K050296 (Varian Medical Systems, 2005) has gone furthest, with 101 descendants of its own.
- 1 other device also cites its predicate K030981.
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.
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 Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1-50 MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators.
Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041403: Eclipse with Aaa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041403
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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