510(k) · Cleared
Recalled · Class II · 2011Rayautoplan 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 Jan 22, 2009 as substantially equivalent to K081281 (Nucletron Corporation, 2008) after a 78-day review. Its family tree reaches back 4 generations to 1987. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 22, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862643 (1987). 11 ancestors in all. 31 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 3 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 2 generations backK031349 OTP 1.2Nucletron Corp. · 2003
- 1 generation backK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- This deviceK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009
- Descendant · cites it directly · 30 of its ownK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- Descendant · 2 generations on · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
- Descendant · 3 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 5 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K100552Raystation Version 1.0Raysearch Laboratories AB · 2010 · cites it directly30descendants
- K120387RaystationRaysearch Laboratories AB · 2012 · 2 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 3 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 4 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −3 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −2 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| −1 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| 0 (this device) | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | — |
| +1 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| +2 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
| +3 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +4 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +5 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy)Summary page 1…Medical charged-particle radiation therapy system (21 CFR 892 5050, Product Code MUJ) 5 7 Predicate devices Oncentra MasterPlan v3 1 510(k) number K081281 5 8 Device description RayAutoplan is a stand-alone software program that generates a number of treatment plans, based on… | 2008 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100552 | Raystation Version 1.0 | 2010 | 30 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2011 | Class II | Z-2444-2012 | Labeling mix-ups | This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered… |
| May 30, 2011 | Class II | Z-2378-2012 | Labeling False and Misleading | This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K100552 (Raysearch Laboratories AB, 2010) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K081281.
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. 2009, 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?
RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of inchvidually optumized IMRT plans and presents their characteristics to the user ina GUI Among the generated plans, the user selects and clincally approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient The intended users of RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083264: Rayautoplan 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/K083264
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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