# K133227: Smart Segmentation - Knowledge Based Contouring

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 14, 2014 after 144 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: 8 generations back to K010975 (2001). 19 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102011: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2010) Summary page 1.
- K112778: Smart Segmentation-Knowledge Based Contouring, Varian Medical Systems (2011) Summary page 1.

## Most influential descendants
- 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/K133227
Methodology: https://510kreport.com/methodology