# K172858: PreOp

- Pathway: 510(k) (Traditional)
- Applicant: Epilog
- Decided: Jan 8, 2018 after 110 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K002631 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092844: Geosource, Electrical Geodesics, Inc. (2010) Summary page 4.
- K001781: Curry Multimodal Neuroimaging Software, Neurosoft, Inc. (2001) Summary page 4.

## Most influential descendants
- K252565: PreOp v3 (2026), 0 descendants of its own
- K250239: NeuroMatch (2025), 0 descendants of its own

## Indications for use
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

Source page: https://510kreport.com/device/K172858
Methodology: https://510kreport.com/methodology