# K080799: Atlas-Based Autosegmentation

- Pathway: 510(k) (Traditional)
- Applicant: Computerized Medical Systems, Inc.
- Decided: Aug 7, 2008 after 139 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 6 generations back to K914698 (1992). 24 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053584: Iplan RT Dose, Brainlab AG (2006) Summary page 1.
- K041577: PINNACLE3 Radiation Therapy Planning System, Adac Laboratories (2004) Summary page 1.
- K061006: Ikoengelo, Ikoetech, LLC (2006) Summary page 1.

## Most influential descendants
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864 (2010), 18 descendants of its own
- K151380: syngo.via RT Image Suite (2015), 9 descendants of its own
- K111311: Segmentation Assistant for Prostate-Auto Contouring (2011), 9 descendants of its own
- K162370: syngo.via RT Image Suite (2016), 8 descendants of its own
- K151887: syngo VSim (2015), 8 descendants of its own

## Indications for use
Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.

Source page: https://510kreport.com/device/K080799
Methodology: https://510kreport.com/methodology