# K032550: Exomio, Model 2.0 SP1

- Pathway: 510(k) (Special)
- Applicant: Medcom GmbH
- Decided: Sep 25, 2003 after 38 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: 2 generations back to K992751 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022219: Exomio, Model 1.1, Medcom GmbH (2002)

## Indications for use
The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment planning tools tct the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3D 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/K032550
Methodology: https://510kreport.com/methodology