510(k) · Cleared
Recalled · Class II · 2014Raystation Version 1.0
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 Mar 12, 2010 as substantially equivalent to K083264 (Raysearch Laboratories AB, 2009) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1987. 30 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 12, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862643 (1987). 12 ancestors in all. 30 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 4 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 3 generations backK031349 OTP 1.2Nucletron Corp. · 2003
- 2 generations backK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- 1 generation backK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- This deviceK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010
- Descendant · cites it directly · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
- Descendant · 2 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 4 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 5 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K120387RaystationRaysearch Laboratories AB · 2012 · cites it directly22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 2 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 3 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 4 generations on17descendants
- K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −4 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −3 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| −2 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| −1 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| 0 (this device) | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | — |
| +1 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
| +2 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +3 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +4 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
| +5 | K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K083264 | Rayautoplan 1.0Summary page 1…-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate devices RayAutoplan 1.0 5 10(k) number K083264 Oncentra MasierPlan 3.1 510(k) number K(081281 5.6 Device description RayStati… | 2009 |
| * | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy)Summary page 1…5.7 Predicate devices RayAutoplan 1.0 5 10(k) number K083264 Oncentra MasierPlan 3.1 510(k) number K(081281 5.6 Device description RayStation is a treatment planning system, i.e. a software program for planning and… | 2008 |
What descends from it? (30)
See all 302 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 |
|---|---|---|---|---|
| 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. |
| Dec 6, 2011 | Not classified | Z-1317-2012 | Device Design | An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient. |
| Oct 19, 2011 | Not classified | Z-0359-2012 | Device Design | The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K120387 (Raysearch Laboratories AB, 2012) has gone furthest, with 22 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. 2010, 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/K100552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100552: Raystation Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100552
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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