510(k) · Cleared
Recalled · Class II · 2023Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eckert & Ziegler Bebig GmbH · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 20, 2015 as substantially equivalent to K123263 (Eckert & Ziegler Bebig GmbH, 2013) after a 310-day review. Its family tree reaches back 5 generations to 1991. It has been recalled once.
- Decided
- May 20, 2015
- Review
- 310 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911612 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- 4 generations backK983343 Plato Brachytheraphy, Model V. 14.0Nucletron Corp. · 1999
- 3 generations backK081112 Flexiplan Brachytherapy Treatment Planning SystemIsodose Control B.V. · 2008
- 2 generations backK091145 Flexiplan 3D and 3D+Isodose Control B.V. · 2009
- 1 generation backK123263 Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH · 2013
- This deviceK141900 Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including…Eckert & Ziegler Bebig GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| −4 | K983343 | Plato Brachytheraphy, Model V. 14.0 | Nucletron Corp. | 1999 | — |
| −3 | K081112 | Flexiplan Brachytherapy Treatment Planning System | Isodose Control B.V. | 2008 | — |
| −2 | K091145 | Flexiplan 3D and 3D+ | Isodose Control B.V. | 2009 | — |
| −1 | K123263 | Hdrplus, Add in Prostate Module for Hdrplus | Eckert & Ziegler Bebig GmbH | 2013 | — |
| 0 (this device) | K141900 | Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module | Eckert & Ziegler Bebig GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K123263 | Hdrplus, Add in Prostate Module for HdrplusSummary page 4…Manufacturer 510(k) # HDRplus Eckert & Ziegler BEBIG GmbH K123263 7.4 Description of the Device 7.4.1 SagiPlan SagiPlan is a software package which runs on a Windows – based PC and is… | 2013 |
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 |
|---|---|---|---|---|
| Oct 17, 2023 | Class II | Z-0517-2024 | Software Design Change | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2015, 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?
SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.
SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data.
SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141900: Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141900
Report an extraction error
Are you the manufacturer?
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