510(k) · Cleared
Recalled · Class II · 2025RayStation
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 24, 2020 as substantially equivalent to K190387 (RaySearch Laboratories AB (PUBL), 2019) after a 204-day review. Its family tree reaches back 15 generations to 2001. 6 later devices descend from it. It has been recalled 14 times.
- Decided
- Sep 24, 2020
- Review
- 204 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 15 generations to K010975 (2001). 70 ancestors in all, the oldest K802809 (1981). 6 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations between
- 3 generations backK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 2 generations backK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- 1 generation backK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- This deviceK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020
- Descendant · cites it directly · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 2 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 3 generations on · 3 of its ownK220141 RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · Recalled
- Descendant · 4 generations on · 2 of its ownK222312 RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · Recalled
- Descendant · 5 generations on · 1 of its ownK240398 RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A…RaySearch Laboratories AB (PUBL) · 2025 · Recalled
Show all 15 generations
- Root · 15 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 14 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 13 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 12 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 11 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 10 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 8 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 7 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 6 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 5 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 4 generations backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 3 generations backK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 2 generations backK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- 1 generation backK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- This deviceK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · cites it directly5descendants
- K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 2 generations on4descendants
- K220141RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · 3 generations on3descendants
- K222312RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · 4 generations on2descendants
- K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL) · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −14 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −13 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −12 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −11 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −10 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −9 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −8 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −7 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −6 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| −5 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| −4 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| −3 | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | 6 |
| −2 | K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018 | 7 |
| −1 | K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019 | 32 |
| 0 (this device) | K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020 | — |
| +1 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +2 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | 8 |
| +3 | K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022 | 6 |
| +4 | K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023 | 6 |
| +5 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation… | RaySearch Laboratories AB (PUBL) | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 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 18.7 · 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 |
|---|---|---|---|
| * | K190387 | RayStationSummary page 4…Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device RayStation 8.1 K190387 5.8 Device description RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software pr… | 2019 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210645 | RayStation 10.1 | 2021 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2025 | Class II | Z-2489-2025 | 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-1187-2025 | 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-1746-2024 | Software design | Potential for reported SSD to be too high. |
| Mar 28, 2024 | Class II | Z-1745-2024 | 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. |
| Jun 1, 2022 | Class II | Z-1403-2022 | Software change control | An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare. |
| Jun 8, 2021 | Class II | Z-2138-2021 | Under Investigation by firm | Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. |
| Apr 21, 2021 | Class II | Z-1838-2021 | Under Investigation by firm | Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in… |
| Apr 7, 2021 | Class II | Z-1598-2021 | Software design | When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the… |
| Mar 25, 2021 | Class II | Z-1427-2021 | Under Investigation by firm | Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. |
| Feb 22, 2021 | Class II | Z-1597-2021 | Software design | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning… |
| Jan 22, 2021 | Class II | Z-2039-2023 | Software design | A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an… |
| Nov 11, 2020 | Class II | Z-0589-2021 | Software design | Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch… |
| Oct 8, 2020 | Class II | Z-0478-2021 | Software design | If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI. |
The 5 latest of 14 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 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 25 of the 70 ancestors have a recall of any class.
- Of its descendants, K210645 (RaySearch Laboratories AB (PUBL), 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K190387.
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. 2020, 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 designed for treatment planning and analysis of radiation therapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation 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/K200569 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200569: RayStation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200569
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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