510(k) · Cleared
ClearedFlexiplan 3D and 3D+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isodose Control B.V. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 27, 2009 as substantially equivalent to K081112 (Isodose Control B.V., 2008) after a 37-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- May 27, 2009
- Review
- 37 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911612 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 2 generations backK983343 Plato Brachytheraphy, Model V. 14.0Nucletron Corp. · 1999
- 1 generation backK081112 Flexiplan Brachytherapy Treatment Planning SystemIsodose Control B.V. · 2008
- This deviceK091145 Flexiplan 3D and 3D+Isodose Control B.V. · 2009
- Descendant · cites it directly · 1 of its ownK123263 Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK141900 Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including…Eckert & Ziegler Bebig GmbH · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −2 | K983343 | Plato Brachytheraphy, Model V. 14.0 | Nucletron Corp. | 1999 | — |
| −1 | K081112 | Flexiplan Brachytherapy Treatment Planning System | Isodose Control B.V. | 2008 | — |
| 0 (this device) | K091145 | Flexiplan 3D and 3D+ | Isodose Control B.V. | 2009 | — |
| +1 | K123263 | Hdrplus, Add in Prostate Module for Hdrplus | Eckert & Ziegler Bebig GmbH | 2013 | — |
| +2 | K141900 | Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module | Eckert & Ziegler Bebig GmbH | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K081112 | Flexiplan Brachytherapy Treatment Planning SystemSummary page 1…Manufacturer 510(k) # Flexiplan Isodose Control BV K081112 6.4. Description of the Device 6.4.1. Flexiplan Flexiplan is a software package which runs on a Windows - based PC and is used… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123263 | Hdrplus, Add in Prostate Module for Hdrplus | 2013 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123263 (Eckert & Ziegler Bebig GmbH, 2013) has gone furthest, with 1 descendant of its own.
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?
Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals.
Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control,
Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091145: Flexiplan 3D and 3D+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091145
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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