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 · IYE Accelerator, Linear, Medical
Cleared on Dec 29, 2011 as substantially equivalent to K083591 (Ikoetech, LLC, 2008) and 1 other predicate after a 94-day review. Its family tree reaches back 5 generations to 2001. 5 later devices descend from it.
- Decided
- Dec 29, 2011
- Review
- 94 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010975 (2001). 15 ancestors in all, the oldest K923851 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 3 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 2 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 1 generation backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- This deviceK112778 Smart Segmentation-Knowledge Based ContouringVarian Medical Systems · 2011
- Descendant · cites it directly · 4 of its ownK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK203469 AI SegmentationVarian Medical Systems, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK212274 INT ContourCarina Medical, LLC · 2022
- Descendant · 4 generations on · 0 of its ownK211881 AI SegmentationVarian Medical Systems, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K133227Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014 · cites it directly4descendants
- K141248Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014 · 2 generations on3descendants
- K203469AI SegmentationVarian Medical Systems, Inc. · 2021 · 3 generations on1descendant
- K212274INT ContourCarina Medical, LLC · 2022 · 3 generations on0descendants
- K211881AI SegmentationVarian Medical Systems, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −4 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −2 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −1 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| 0 (this device) | K112778 | Smart Segmentation-Knowledge Based Contouring | Varian Medical Systems | 2011 | — |
| +1 | K133227 | Smart Segmentation - Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| +2 | K141248 | Smart Segmentation Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| +3 | K203469 | AI Segmentation | Varian Medical Systems, Inc. | 2021 | — |
| +3 | K212274 | INT Contour | Carina Medical, LLC | 2022 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K083591 | Ikoengelo, Version 2Summary page 1…Product Code: 90 IYE Cammon/Usual Name: Smart Segmentation KBC Predicate Device: lKOEngelo Tm Radiation Therapy Simulation System: (K083591) Eclipse Treatment Planning System: (K071873) Device Description: Smart Segm… | 2008 |
| * | K071873 | Modification to Eclipse Treatment Planning SystemSummary page 1…Predicate Device: lKOEngelo Tm Radiation Therapy Simulation System: (K083591) Eclipse Treatment Planning System: (K071873) Device Description: Smart Segmentation - Knowledge Based Contouring is a software only… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133227 | Smart Segmentation - Knowledge Based Contouring | 2014 | 4 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K133227 (Varian Medical Systems, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K083591.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
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/K112778 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112778: Smart Segmentation-Knowledge Based Contouring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112778
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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