510(k) · Cleared
ClearedOTP 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 7, 2003 as substantially equivalent to K970236 (Theratronics, Inc., 1997) after a 100-day review. Its family tree reaches back 2 generations to 1987. 59 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 100 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862643 (1987). 7 ancestors in all. 59 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
- 1 generation backK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
- This deviceK031349 OTP 1.2Nucletron Corp. · 2003
- Descendant · cites it directly · 54 of its ownK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
- Descendant · 2 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled
- Descendant · 2 generations on · 30 of its ownK100552 Raystation Version 1.0Raysearch Laboratories AB · 2010 · Recalled
- Descendant · 3 generations on · 27 of its ownK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · cites it directly54descendants
- K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 2 generations on34descendants
- K083264Rayautoplan 1.0Raysearch Laboratories AB · 2009 · 2 generations on31descendants
- K100552Raystation Version 1.0Raysearch Laboratories AB · 2010 · 2 generations on30descendants
- K102216Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862643 | Radiation Oncology Computer Sys Treatment Planning | Pacific Physics, Inc. | 1987 | — |
| −1 | K970236 | Theraplan Plus Version 1.2 | Theratronics, Inc. | 1997 | — |
| 0 (this device) | K031349 | OTP 1.2 | Nucletron Corp. | 2003 | — |
| +1 | K081281 | Ocentra Masterplan 3.1 (Ocentra Brachy) | Nucletron Corporation | 2008 | 2 |
| +2 | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | 12 |
| +2 | K083264 | Rayautoplan 1.0 | Raysearch Laboratories AB | 2009 | 2 |
| +2 | K100552 | Raystation Version 1.0 | Raysearch Laboratories AB | 2010 | 4 |
| +3 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 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? (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 |
|---|---|---|---|
| * | K970236 | Theraplan Plus Version 1.2Summary page 2…e of treating patients with cancer. Summary of technological considerations: OTP is substantially equivalent to the cleared predicate device, TheraPlan Plus, 510( k)#: K970236. / - I 7) t Name: Tim Bateman Date… | 1997 |
What descends from it? (59)
See all 592 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K081281 (Nucletron Corporation, 2008) has gone furthest, with 54 descendants of its own.
- 2 other devices also cite its predicate K970236.
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.
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?
OTP is radiation treatment planning software designed to analyze and plan rahation treatments in three dimensions for the purpose of treating patients with cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031349: OTP 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031349
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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