510(k) · Cleared
Recalled · Class II · 2025RayStation 11.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
RaySearch Laboratories AB (PUBL) · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 8, 2021 as substantially equivalent to K210645 (RaySearch Laboratories AB (PUBL), 2021) after an 84-day review. Its family tree reaches back 17 generations to 2001. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 8, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 17 generations to K010975 (2001). 126 ancestors in all, the oldest K802809 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 13 generations between
- 3 generations backK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- 2 generations backK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020 · Recalled
- 1 generation backK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- This deviceK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021
- Descendant · cites it directly · 3 of its ownK220141 RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK222312 RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK240398 RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A…RaySearch Laboratories AB (PUBL) · 2025 · Recalled
- Descendant · 4 generations on · 0 of its ownK252109 RayStation (2024A SP3)RaySearch Laboratories AB (PUBL) · 2025
Show all 17 generations
- Root · 17 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 16 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 15 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 14 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 13 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 12 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 11 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 10 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 9 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 8 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 7 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 6 generations backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 5 generations backK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 4 generations backK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- 3 generations backK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- 2 generations backK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020 · Recalled
- 1 generation backK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- This deviceK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021
Most influential descendants
Showing 4 of 4 · See all- K220141RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · cites it directly3descendants
- K222312RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · 2 generations on2descendants
- K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL) · 2025 · 3 generations on1descendant
- K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL) · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −16 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −15 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −14 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −13 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −12 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −11 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −10 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −9 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −8 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| −7 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| −6 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| −5 | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | 6 |
| −4 | K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018 | 7 |
| −3 | K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019 | 32 |
| −2 | K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020 | 14 |
| −1 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| 0 (this device) | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | — |
| +1 | K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022 | 6 |
| +2 | K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023 | 6 |
| +3 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation… | RaySearch Laboratories AB (PUBL) | 2025 | 2 |
| +4 | K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K210645 | RayStation 10.1 Cleared while this submission was under review Summary page 6…tment planning system 1.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 1.7 Predicate devices K210645 RayStation 10.1 1.8 Device description RayStation is a treatment planning system for planning, analysis and a… | 2021 |
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 |
|---|---|---|---|
| K220141 | RayStation 11B | 2022 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2025 | Class II | Z-1103-2026 | Under Investigation by firm | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of… |
| Aug 8, 2025 | Class II | Z-2491-2025 | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. |
| Jan 16, 2025 | Class II | Z-1189-2025 | Under Investigation by firm | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in… |
| Mar 28, 2024 | Class II | Z-1748-2024 | Software design | Potential for reported SSD to be too high. |
| Feb 23, 2024 | Class II | Z-1482-2024 | Under Investigation by firm | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. |
| Feb 11, 2022 | Class II | Z-0850-2022 | Under Investigation by firm | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. |
| Dec 30, 2021 | Class II | Z-0732-2022 | Software design | If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened… |
| Sep 22, 2021 | Class II | Z-0849-2022 | Device Design | An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 44 of the 126 ancestors have a recall of any class.
- Of its descendants, K220141 (RaySearch Laboratories AB (PUBL), 2022) 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. 2021, 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?
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211867: RayStation 11.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211867
Report an extraction error
Are you the manufacturer?
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