510(k) · Cleared
Recalled · Class II · 2016Oncentra, Oncentra External Beam, Oncentra Brachy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Inc. D/B/A Nucletron Corporation · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 2, 2012 as substantially equivalent to K081281 (Nucletron Corporation, 2008) and 1 other predicate after a 48-day review. Its family tree reaches back 4 generations to 1987. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 2, 2012
- Review
- 48 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862643 (1987). 11 ancestors in all. 9 later devices descend from it, 2 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 deviceK121448 Oncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation · 2012
- Descendant · cites it directly · 7 of its ownK132971 MonacoImpac Medical Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132971MonacoImpac Medical Systems, Inc. · 2013 · cites it directly7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 2 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 3 generations on5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 4 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 5 generations on3descendants
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) | K121448 | Oncentra, Oncentra External Beam, Oncentra Brachy | Elekta Inc. D/B/A Nucletron Corporation | 2012 | — |
| +1 | K132971 | Monaco | Impac Medical Systems, Inc. | 2013 | 4 |
| +2 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +3 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +4 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +5 | K202789 | Monaco Rtp System | Elekta Solutions AB | 2021 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy)Summary page 1…FICAITON Our modified device is based on the legally marketed device cited in the table below: Nucletron BV Oncentra MasterPlan 3.1 K081281 Nucletron BV PLATO Brachytherapy 14.0 K983343 4. OVERALL DESCRIPTION OF ONCENTR… | 2008 |
| * | K983343 | Plato Brachytheraphy, Model V. 14.0Summary page 1…he table below: Nucletron BV Oncentra MasterPlan 3.1 K081281 Nucletron BV PLATO Brachytherapy 14.0 K983343 4. OVERALL DESCRIPTION OF ONCENTRA 4.2 Oncentra 4.2 is an update of Qncentra Master-Plan 3.1- they are the same… | 1999 |
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Dec 23, 2016 | Class II | Z-0987-2017 | Software design | Cross profile for Varian 60 degree wedge shows "horns." |
| Dec 18, 2015 | Class II | Z-0604-2016 | Software design | When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target… |
| May 21, 2015 | Class II | Z-1712-2015 | Other | Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 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, K132971 (Impac Medical Systems, Inc., 2013) has gone furthest, with 7 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. 2012, 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 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/K121448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121448: Oncentra, Oncentra External Beam, Oncentra Brachy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121448
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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