510(k) · Cleared
ClearedSmart Segmentation Knowledge Based Contouring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 5, 2014 as substantially equivalent to K133227 (Varian Medical Systems, Inc., 2014) after a 114-day review. Its family tree reaches back 9 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010975 (2001). 20 ancestors in all, the oldest K923851 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 1 generation backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- This deviceK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK203469 AI SegmentationVarian Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK212274 INT ContourCarina Medical, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK211881 AI SegmentationVarian Medical Systems, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 7 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 6 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 5 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 1 generation backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- This deviceK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −8 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −7 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −6 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −5 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −4 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −3 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −2 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −1 | K133227 | Smart Segmentation - Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K141248 | Smart Segmentation Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K203469 | AI Segmentation | Varian Medical Systems, Inc. | 2021 | — |
| +1 | K212274 | INT Contour | Carina Medical, LLC | 2022 | — |
| +2 | K211881 | AI Segmentation | Varian Medical Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K133227 | Smart Segmentation - Knowledge Based ContouringSummary page 5…Class II Product Code MUJ 3. Predicate Devices: Smart Segmentation Knowledge Based Contouring K133227 4. Description of the Device: The Smart Segmentation Knowledge Based Contouring was most recently cleared as the… | 2014 |
What descends from it? (3)
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 13 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K203469 (Varian Medical Systems, Inc., 2021) 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. 2014, 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?
Smart Segmentation Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141248: Smart Segmentation Knowledge Based Contouring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141248
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