# K982857: Helax-Imcon, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Helax AB
- Decided: Nov 4, 1998 after 83 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 K952313 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952313: Varis Images, Including Ximatron Digital Imaging Option, Varian Assoc., Inc. (1995) Summary page 1.

## Indications for use
Patients planned for radiation treatment, either to verify a prescribed plan, or to help at the planning at the simulator.

Source page: https://510kreport.com/device/K982857
Methodology: https://510kreport.com/methodology