510(k) · Cleared
Recalled · Class II · 2015Raystation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raysearch Laboratories AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 6, 2012 as substantially equivalent to K100552 (Raysearch Laboratories AB, 2010) and 1 other predicate after a 59-day review. Its family tree reaches back 6 generations to 1987. 22 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 6, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 6 generations to K862643 (1987). 29 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 5 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 4 generations backK031349 OTP 1.2Nucletron Corp. · 2003
- 3 generations backK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- 2 generations backK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- 1 generation backK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- This deviceK120387 RaystationRaysearch Laboratories AB · 2012
- Descendant · cites it directly · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 3 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- Descendant · 5 generations on · 15 of its ownK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K130617RaystationRaysearch Laboratories AB · 2013 · cites it directly21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 2 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 3 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 4 generations on16descendants
- K170355RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −5 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −4 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| −3 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| −2 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| −1 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| 0 (this device) | K120387 | Raystation | Raysearch Laboratories AB | 2012 | — |
| +1 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +2 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +3 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +4 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| +5 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K100552 | Raystation Version 1.0Summary page 1…ssification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate devices RayStation 1.0 K100552 IPLAN RT K103246 5.8 Device description RayStation 2.5 is a treatment planning system, i.e. a… | 2010 |
| * | K103246 | Iplan RTSummary page 1…ged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate devices RayStation 1.0 K100552 IPLAN RT K103246 5.8 Device description RayStation 2.5 is a treatment planning system, i.e. a software program for planning and ana… | 2011 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130617 | Raystation | 2013 | 21 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2015 | Class II | Z-1679-2015 | Software Design Change | RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing. |
| Feb 14, 2014 | Class II | Z-1481-2014 | Software design | RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. |
| Feb 6, 2014 | Class II | Z-1307-2014 | Software Design Change | Potential for dose errors due to software program errors. |
| Oct 23, 2013 | Class II | Z-0281-2014 | Software design | Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees. |
| Feb 15, 2013 | Class II | Z-1419-2013 | Software change control | Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning. |
| May 9, 2012 | Class II | Z-2324-2012 | Device Design | The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information… |
The 5 latest of 6 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 25 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K130617 (Raysearch Laboratories AB, 2013) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K100552.
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. 2012, 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/K120387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120387: Raystation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120387
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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