510(k) · Cleared
Recalled · Class II · 2022Oncentra Brachy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron B.V. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 13, 2014 as substantially equivalent to K121448 (Elekta Inc. D/B/A Nucletron Corporation, 2012) after a 277-day review. Its family tree reaches back 5 generations to 1987. It has been recalled 3 times.
- Decided
- Jun 13, 2014
- Review
- 277 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862643 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
- 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 backK121448 Oncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation · 2012 · Recalled
- This deviceK132816 Oncentra BrachyNucletron B.V. · 2014
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 | K121448 | Oncentra, Oncentra External Beam, Oncentra Brachy | Elekta Inc. D/B/A Nucletron Corporation | 2012 | 3 |
| 0 (this device) | K132816 | Oncentra Brachy | Nucletron B.V. | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K121448 | Oncentra, Oncentra External Beam, Oncentra BrachySummary page 2…pproval by qualified medical personnel. Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4,4 includes all Oncentra software… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2022 | Class II | Z-0719-2023 | Software design | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling |
| Oct 13, 2021 | Class II | Z-0182-2022 | Software design | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. |
| Aug 10, 2017 | Class II | Z-0050-2018 | Software design | Incorrect source step size may occur in the software plans |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K121448.
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. 2014, 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?
Oncentra is a radiation therapy 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/K132816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132816: Oncentra Brachy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132816
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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