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 27, 2017 as substantially equivalent to K170355 (RaySearch Laboratories AB (PUBL), 2017) after a 33-day review. Its family tree reaches back 12 generations to 2001. 13 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 27, 2017
- Review
- 33 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010975 (2001). 67 ancestors in all, the oldest K802809 (1981). 13 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 2 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 1 generation backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- This deviceK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017
- Descendant · cites it directly · 12 of its ownK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- Descendant · 2 generations on · 11 of its ownK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- Descendant · 3 generations on · 6 of its ownK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020 · Recalled
- Descendant · 4 generations on · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 5 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
Show all 12 generations
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 10 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 9 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 8 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 5 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 4 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 3 generations backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- 2 generations backK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
- 1 generation backK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- This deviceK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K180379RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · cites it directly12descendants
- K190387RayStationRaySearch Laboratories AB (PUBL) · 2019 · 2 generations on11descendants
- K200569RayStationRaySearch Laboratories AB (PUBL) · 2020 · 3 generations on6descendants
- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · 4 generations on5descendants
- K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −11 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −10 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −9 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −8 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −7 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −6 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −5 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −4 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −3 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| −2 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
| −1 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| 0 (this device) | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | — |
| +1 | K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018 | 7 |
| +2 | K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019 | 32 |
| +3 | K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020 | 14 |
| +4 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +5 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | 8 |
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 |
|---|---|---|
| 2018 | 1 | 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? (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 |
|---|---|---|---|
| * | K170355 | RayStation 6Summary page 4…assification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device RayStation 6.0 K170355 5.8 Device description RayStation 6.1 is a radiation therapy treatment planning system, i.e. a software program for pla… | 2017 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180379 | RayStation 7 | 2018 | 12 |
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-2494-2025 | 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-1192-2025 | 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, 2018 | Class II | Z-2290-2018 | Software design | The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning. |
| Jan 26, 2018 | Class II | Z-1275-2018 | Device Design | Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient. |
| Nov 20, 2017 | Class II | Z-1930-2019 | Software design | When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong |
| Jul 17, 2017 | Class II | Z-0380-2018 | Device Design | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA… |
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 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 22 of the 67 ancestors have a recall of any class.
- Of its descendants, K180379 (RaySearch Laboratories AB (PUBL), 2018) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K170355.
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. 2017, 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/K171536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171536: RayStation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171536
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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