# K022219: Exomio, Model 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Medcom GmbH
- Decided: Oct 7, 2002 after 90 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992751 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992751: Somavision, Varian Assoc., Inc. (2000) Summary page 1.

## Most influential descendants
- K032550: Exomio, Model 2.0 SP1 (2003), 0 descendants of its own

## Indications for use
The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment planning tools to the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3-D visualization of the virtual treatment setup. Moreover, it includes useful treatment setup export capabilities to enable the communication with compatible medical devices.

Source page: https://510kreport.com/device/K022219
Methodology: https://510kreport.com/methodology