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 Jun 19, 2019 as substantially equivalent to K180379 (RaySearch Laboratories AB (PUBL), 2018) after a 120-day review. Its family tree reaches back 14 generations to 2001. 11 later devices descend from it. It has been recalled 32 times.
- Decided
- Jun 19, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 32
- Predicates
- 1
Its longest line of descent runs back 14 generations to K010975 (2001). 69 ancestors in all, the oldest K802809 (1981). 11 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 10 generations between
- 3 generations backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 2 generations backK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 1 generation backK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- This deviceK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019
- Descendant · cites it directly · 6 of its ownK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020 · Recalled
- Descendant · 2 generations on · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 3 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 4 generations on · 3 of its ownK220141 RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
Show all 14 generations
- Root · 14 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 13 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 12 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 11 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 10 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 9 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 8 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 6 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 5 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 4 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 3 generations backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 2 generations backK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- 1 generation backK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- This deviceK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
2020high 3 (2021) · low 0 (2024)2026
Most influential descendants
Showing 5 of 11 · See all- K200569RayStationRaySearch Laboratories AB (PUBL) · 2020 · cites it directly6descendants
- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · 2 generations on5descendants
- K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 3 generations on4descendants
- K220141RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · 4 generations on3descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −13 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −12 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −11 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −10 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −9 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −8 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −7 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −6 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −5 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| −4 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| −3 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| −2 | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | 6 |
| −1 | K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018 | 7 |
| 0 (this device) | K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019 | — |
| +1 | K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020 | 14 |
| +2 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +3 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | 8 |
| +4 | K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022 | 6 |
| +1 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K180379 | RayStation 7Summary page 4…assification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device RayStation 7.0 K180379 5.8 Device description RayStation 8.1 is a radiation therapy treatment planning system, i.e. a software program for pla… | 2018 |
What descends from it? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2025 | Class II | Z-2488-2025 | 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-1186-2025 | 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-1744-2024 | Software design | Potential for reported SSD to be too high. |
| Mar 28, 2024 | Class II | Z-1743-2024 | 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 17, 2023 | Class II | Z-1281-2023 | Under Investigation by firm | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the… |
| May 26, 2020 | Class II | Z-2426-2020 | Under Investigation by firm | It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the… |
| May 18, 2020 | Class II | Z-2343-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2351-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2341-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2352-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2342-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2344-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2348-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2349-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2340-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2350-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2353-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2347-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2346-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2339-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| May 18, 2020 | Class II | Z-2345-2020 | Software design | Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose. |
| Mar 4, 2020 | Class II | Z-1598-2020 | Under Investigation by firm | Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a… |
| Feb 20, 2020 | Class II | Z-1462-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1468-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1467-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1463-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1465-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1466-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Feb 20, 2020 | Class II | Z-1464-2020 | Under Investigation by firm | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal… |
| Dec 19, 2019 | Class II | Z-0866-2020 | Software design | Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard… |
| Nov 18, 2019 | Class II | Z-0736-2020 | Software design | Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported. |
The 5 latest of 32 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 18 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 69 ancestors have a recall of any class.
- Of its descendants, K200569 (RaySearch Laboratories AB (PUBL), 2020) has gone furthest, with 6 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. 2019, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2007high 16 (2009) · low 4 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
2007high 233 (2026) · low 30 (2017)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
2007high 23 (2010) · low 0 (2024)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
2007high 78 (2010) · low 9 (2024)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/K190387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190387: RayStation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190387
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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