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 Apr 8, 2016 as substantially equivalent to K141860 (Raysearch Laboratories AB, 2014) after an 80-day review. Its family tree reaches back 10 generations to 2001. 16 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 8, 2016
- Review
- 80 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010975 (2001). 65 ancestors in all, the oldest K802809 (1981). 16 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 1 generation backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- This deviceK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016
- Descendant · cites it directly · 15 of its ownK170355 RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK171536 RayStationRaySearch Laboratories AB (PUBL) · 2017 · Recalled
- Descendant · 3 generations on · 12 of its ownK180379 RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · Recalled
- Descendant · 4 generations on · 11 of its ownK190387 RayStationRaySearch Laboratories AB (PUBL) · 2019 · Recalled
- Descendant · 5 generations on · 6 of its ownK200569 RayStationRaySearch Laboratories AB (PUBL) · 2020 · Recalled
Show all 10 generations
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 8 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 7 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 6 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- 1 generation backK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- This deviceK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K170355RayStation 6RaySearch Laboratories AB (PUBL) · 2017 · cites it directly15descendants
- K171536RayStationRaySearch Laboratories AB (PUBL) · 2017 · 2 generations on13descendants
- K180379RayStation 7RaySearch Laboratories AB (PUBL) · 2018 · 3 generations on12descendants
- K190387RayStationRaySearch Laboratories AB (PUBL) · 2019 · 4 generations on11descendants
- K200569RayStationRaySearch Laboratories AB (PUBL) · 2020 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −9 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −8 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −7 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −6 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −5 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −3 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −2 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| −1 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| 0 (this device) | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | — |
| +1 | K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017 | 1 |
| +2 | K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017 | 6 |
| +3 | K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018 | 7 |
| +4 | K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019 | 32 |
| +5 | K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020 | 14 |
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 |
|---|---|---|
| 2017 | 3 | 0 |
| 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 |
|---|---|---|---|
| * | K141860 | RaystationSummary page 4…assification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device RayStation 4.5 K141860 5.8 Device description RayStation 5 is a radiation therapy treatment planning system, i.e. a software program for plann… | 2014 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170355 | RayStation 6 | 2017 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2025 | Class II | Z-1194-2025 | 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… |
| Jan 18, 2017 | Class II | Z-1815-2017 | Device Design | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an… |
| Nov 9, 2016 | Class II | Z-0721-2017 | Software design | Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient… |
| Oct 11, 2016 | Class II | Z-0720-2017 | Software design | An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT… |
| Sep 1, 2016 | Class II | Z-0038-2017 | Under Investigation by firm | RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of… |
| Jul 1, 2016 | Class II | Z-2206-2016 | Under Investigation by firm | An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another… |
| May 30, 2016 | Class II | Z-0079-2017 | Software design | For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a… |
The 5 latest of 7 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 15 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 65 ancestors have a recall of any class.
- Of its descendants, K170355 (RaySearch Laboratories AB (PUBL), 2017) has gone furthest, with 15 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. 2016, 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/K160093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160093: RayStation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160093
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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