# K252565: PreOp v3

- Pathway: 510(k) (Special)
- Applicant: Clouds of Care
- Decided: Feb 13, 2026 after 183 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: 3 generations back to K002631 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172858: PreOp, Epilog (2018) Summary page 5.

## Indications for use
PreOp V3 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/K252565
Methodology: https://510kreport.com/methodology