510(k) · Cleared
ClearedPlanOne 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosylab Jsc, Control System Laboratory · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Nov 20, 2025 as substantially equivalent to K230557 (Varian Medical Systems, Inc., 2023) after a 234-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Nov 20, 2025
- Review
- 234 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K010975 (2001). 22 ancestors in all, the oldest K992762 (2000). No later device cites it as a predicate yet.
- Root · 18 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 14 generations between
- 3 generations backK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- 2 generations backK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
- 1 generation backK230557 Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023
- This deviceK250963 PlanOne 1Cosylab Jsc, Control System Laboratory · 2025
Show all 18 generations
- Root · 18 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 17 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 16 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 15 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 14 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 13 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 12 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 11 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 10 generations backK131891 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2013
- 9 generations backK133247 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014
- 8 generations backK141283 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2014 · Recalled
- 7 generations backK152393 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2015 · Recalled
- 6 generations backK170969 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 5 generations backK172163 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2017 · Recalled
- 4 generations backK181145 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2018 · Recalled
- 3 generations backK200608 Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc. · 2020
- 2 generations backK201607 Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc. · 2020
- 1 generation backK230557 Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. · 2023
- This deviceK250963 PlanOne 1Cosylab Jsc, Control System Laboratory · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −17 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −16 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −15 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −14 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −13 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −12 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −11 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −10 | K131891 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2013 | — |
| −9 | K133247 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | — |
| −8 | K141283 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2014 | 1 |
| −7 | K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015 | 1 |
| −6 | K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −5 | K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017 | 1 |
| −4 | K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018 | 1 |
| −3 | K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | 2020 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230557 | Eclipse Treatment Planning System (v18.0)Summary page 6…Page 1 of 9 510(k) #: K250963 3. Legally Marketed Predicate Devices Predicate # K230557 Predicate Trade Name Eclipse Treatment Planning System (v18.0) Product Code MUJ 4. Device Descrip on Summary The Cosylab Tre… | 2023 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K230557.
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. 2025, 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 PlanOne is a software system used to plan radiotherapy treatments for patients with
malignant or benign diseases. PlanOne is used to plan external beam irradiation with photon
and proton beams. The intended users of PlanOne shall be clinically qualified radiation therapy
staff trained in using the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250963: PlanOne 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250963
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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