# K112778: Smart Segmentation-Knowledge Based Contouring

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Dec 29, 2011 after 94 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010975 (2001). 15 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083591: Ikoengelo, Version 2, Ikoetech, LLC (2008) Summary page 1.
- K071873: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K133227: Smart Segmentation - Knowledge Based Contouring (2014), 4 descendants of its own
- K141248: Smart Segmentation Knowledge Based Contouring (2014), 3 descendants of its own
- K203469: AI Segmentation (2021), 1 descendant of its own
- K212274: INT Contour (2022), 0 descendants of its own
- K211881: AI Segmentation (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K112778
Methodology: https://510kreport.com/methodology