510(k) · Cleared
ClearedVirtual Cone (1.0)
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 8, 2026 as substantially equivalent to K242378 (Varian Medical Systems, 2024) after a 124-day review. Its family tree reaches back 19 generations to 2001.
- Decided
- Jul 8, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K010975 (2001). 23 ancestors in all, the oldest K992762 (2000). No later device cites it as a predicate yet.
- Root · 19 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 15 generations between
- 3 generations backK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
- 2 generations backK230557 Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023
- 1 generation backK242378 Eclipse Treatment Planning System (18.1)Varian Medical Systems · 2024
- This deviceK260750 Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 18 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 17 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 16 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 15 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 14 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 13 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 12 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 11 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 10 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 9 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 8 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 7 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 6 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 5 generations backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- 4 generations backK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- 3 generations backK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
- 2 generations backK230557 Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023
- 1 generation backK242378 Eclipse Treatment Planning System (18.1)Varian Medical Systems · 2024
- This deviceK260750 Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −18 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −17 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −16 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −15 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −14 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −13 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −12 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −11 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −10 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −9 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −8 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −7 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −6 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −5 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| −4 | K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | 2020 | — |
| −3 | K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | 2020 | — |
| −2 | K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023 | — |
| −1 | K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024 | — |
| 0 (this device) | K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K242378 | Eclipse Treatment Planning System (18.1)Summary page 5…e radiation therapy system Regulation Number: §892.5050 Product Code: MUJ III. Predicate Device Eclipse Treatment Planning System v18.1 (K242378) IV. Device Description Virtual Cone is software that is based on the technique described by Popple (Popple et al… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 23 ancestors have a recall of any class.
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. 2026, 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 Virtual Cone plan insertion tool is an ESAPI script intended to facilitate the noninvasive treatment of
small, spherical intracranial targets by automating part of the planning process within the Eclipse Treatment
Planning System. It enables the generation, by clinical users, of precise, conformal dose distributions
comparable to those achieved with physical stereotactic cones, streamlining the treatment planning and
delivery process. To achieve this, the script automates the creation of a fixed, small MLC-defined aperture
by generating a standardized control point sequence with sinusoidal dose rate modulation.
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/K260750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260750: Virtual Cone (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260750
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026