510(k) · Cleared
ClearedSegmentation Assistant for Prostate-Auto Contouring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omisa Inc. (Segasist Technologies) · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 17, 2011 as substantially equivalent to K090833 (Medviso, 2009) and 3 other predicates after a 160-day review. Its family tree reaches back 7 generations to 1996. 9 later devices descend from it.
- Decided
- Oct 17, 2011
- Review
- 160 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K954678 (1996). 53 ancestors in all, the oldest K871859 (1987). 9 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 3 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 2 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 1 generation backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- This deviceK111311 Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011
- Descendant · cites it directly · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- 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- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · 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 |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −1 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| 0 (this device) | K111311 | Segmentation Assistant for Prostate-Auto Contouring | Omisa Inc. (Segasist Technologies) | 2011 | — |
| +1 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| +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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K090833 | SegmentSummary page 1…mation for four of these predicates demonstrates substantial equivalence:. These commercial products include: 1. Medviso AB's Segment software cleared for market via K090833 Trade Name: Segment / Image Processing System Product Code: LLZ Classification: 21 CFR 892.2050 Class… | 2009 |
| * | K080799 | Atlas-Based AutosegmentationSummary page 1…Classification: 21 CFR 892.2050 Class: 11 2. Computerized Medical Systems, Inc.'s Atlas-Based Autosegmentation Software, cleared for market via K080799 Trade Name: Atlas-Based Autosegmentation Product Code: LHN and MUJ Classification: 21 CFR 892.5050 Cl… | 2008 |
| * | K083591 | Ikoengelo, Version 2Summary page 1…segmentation Product Code: LHN and MUJ Classification: 21 CFR 892.5050 Class: 11 3. IKOEtech, LLC's lKOEngelo Tm software cleared for market via K083591 Trade Name: lKOEngelo~m Product Code: KPQ Classification: 21 CIFR 892.5840 Class: 11 4. Siemens A… | 2008 |
| * | K071310 | Syngo CT Oncology Software PackageSummary page 1…ame: lKOEngelo~m Product Code: KPQ Classification: 21 CIFR 892.5840 Class: 11 4. Siemens AG, Contouring Software Package, cleared for market via K07131 0 Trade Name: syngo CT Oncology Product Code: JAK Segasist Technologies CONFIDENTIAL… | 2007 |
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)
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 15 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 53 ancestors have a recall of any class.
- Of its descendants, K132944 (Ge Hungary Kft, 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K090833.
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. 2011, 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?
Segasist P-AC contouring software is a standalone software application for Windows platforms that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in Computed Tomography (CT) scans, Magnetic Resonance (MR) images and ultrasound (sonography) scans to aid in patient diagnosis, treatment planning and post-treatment monitoring. The software is intended to be used to provide clinicians with tools to efficiently…
Read the full statement (143 words)
Segasist P-AC contouring software is a standalone software application for Windows platforms that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in Computed Tomography (CT) scans, Magnetic Resonance (MR) images and ultrasound (sonography) scans to aid in patient diagnosis, treatment planning and post-treatment monitoring. The software is intended to be used to provide clinicians with tools to efficiently contour/delineate the prostate gland in volume data and save the results in DICOM and BMP format. The clinician has the ability to use the saved contours directly or import them in other software tools to perform the task at hand.
The clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images. The Segasist P-AC software tool is a compliment to manual contouring techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111311: Segmentation Assistant for Prostate-Auto Contouring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111311
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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