510(k) · Cleared
Recalled · Class II · 2015Ocentra Masterplan 3.1 (Ocentra Brachy)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corporation · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 20, 2008 as substantially equivalent to K031349 (Nucletron Corp., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1987. 54 later devices descend from it. It has been recalled 2 times.
- Decided
- May 20, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862643 (1987). 10 ancestors in all. 54 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 2 generations backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- 1 generation backK031349 OTP 1.2Nucletron Corp. · 2003
- This deviceK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008
- Descendant · cites it directly · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · cites it directly · 31 of its ownK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- Descendant · cites it directly · 30 of its ownK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- Descendant · 2 generations on · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · cites it directly34descendants
- K083264Rayautoplan 1.0Raysearch Laboratories AB · 2009 · cites it directly31descendants
- K100552Raystation Version 1.0Raysearch Laboratories AB · 2010 · cites it directly30descendants
- K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · 2 generations on27descendants
- K120387RaystationRaysearch Laboratories AB · 2012 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −2 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| −1 | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| 0 (this device) | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | — |
| +1 | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | 12 |
| +1 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| +1 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| +2 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| +2 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K031349 | OTP 1.2Summary page 1…Device(s) Our modified device is based on the legally marketed device cited in the table below: Nucletron BV OTP 1.2 K031349 Nucletron B.V PLATO Brachytherapy 14.0 K983343 Description The Oncentra MasterPl… | 2003 |
| * | K983343 | Plato Brachytheraphy, Model V. 14.0Summary page 1…the table below: Nucletron BV OTP 1.2 K031349 Nucletron B.V PLATO Brachytherapy 14.0 K983343 Description The Oncentra MasterPlan 3.1 system is radiation treatment planning software designed to analyze and p… | 1999 |
What descends from it? (54)
See all 545 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 |
|---|---|---|---|---|
| May 21, 2015 | Class II | Z-1712-2015 | Other | Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. |
| Aug 21, 2012 | Class II | Z-0118-2013 | Software design | During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K092132 (Computerized Medical Systems, Inc., 2009) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K031349.
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. 2008, 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?
The Oncentra MasterPlan system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081281: Ocentra Masterplan 3.1 (Ocentra Brachy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081281
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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