510(k) · Cleared
ClearedAI Segmentation
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 2, 2021 as substantially equivalent to K203469 (Varian Medical Systems, Inc., 2021) after a 73-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Sep 2, 2021
- Review
- 73 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010975 (2001). 22 ancestors in all, the oldest K923851 (1992). No later device cites it as a predicate yet.
- Root · 11 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 7 generations between
- 3 generations backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 2 generations backK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 1 generation backK203469 AI SegmentationVarian Medical Systems, Inc. · 2021
- This deviceK211881 AI SegmentationVarian Medical Systems, Inc. · 2021
Show all 11 generations
- Root · 11 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 10 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 9 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 8 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 7 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 4 generations backK102011 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2010 · Recalled
- 3 generations backK133227 Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 2 generations backK141248 Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc. · 2014
- 1 generation backK203469 AI SegmentationVarian Medical Systems, Inc. · 2021
- This deviceK211881 AI SegmentationVarian Medical Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −10 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −9 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −8 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −7 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −6 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −5 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −4 | K102011 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2010 | 5 |
| −3 | K133227 | Smart Segmentation - Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| −2 | K141248 | Smart Segmentation Knowledge Based Contouring | Varian Medical Systems, Inc. | 2014 | — |
| −1 | K203469 | AI Segmentation | Varian Medical Systems, Inc. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K203469 | AI SegmentationSummary page 4…n therapy system MUJ | 21 CFR 892.5050 | Class II PREDICATE DEVICE Predicate Device Name: AI Segmentation (K203469) DEVICE DESCRIPTION AI Segmentation is a web-based application, running in the cloud, that provides a combined deep learning… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 22 ancestors have 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. 2021, 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?
AI Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning. AI Segmentation utilizes a pre-defined set of organ structures in the following regions: head and neck, thorax, pelvis, abdomen. Segmentation results are subject to review and editing by qualified, expert radiation therapy treatment planners. Results of AI Segmentation are utilized in the Eclipse Treatment Planning System where it is the responsibility of a qualified physician to further review, edit as needed, and approve each structure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211881: AI Segmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211881
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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