510(k) · Cleared
ClearedEclipse, Helios Option
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 22, 2002 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 103 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
103 later devices descend from it, 2 citing it directly.
- This deviceK021268 Eclipse, Helios OptionVarian Medical Systems, Inc. · 2002
- 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 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K021268 | Eclipse, Helios Option | Varian Medical Systems, Inc. | 2002 | — |
| +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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K9845432 | CadPlan Helios Option Version 6.0 Number could not be read Summary page 1…rian.com Device Name: Eclipse, Helios Option Classification Name: System, Planning, Radiation Therapy Treatment Predicate Device: CadPlan Helios Option Version 6.0, K9845432 Page 1 of 2 Oncology Systems 3100 Hansen Way Palo Alto, CA 94304-1038 USA rel +1 650 493 4000 www.varian.com === Page 2 ==… |
What descends from it? (103)
See all 1032 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050296 (Varian Medical Systems, 2005) has gone furthest, with 101 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.
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 Helios Option software is used to inversely plan photon radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 - 50 MV.
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/K021268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021268: Eclipse, Helios Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021268
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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