# K222838: iSyncBrain©-C

- Pathway: 510(k) (Traditional)
- Applicant: iMediSync, Inc.
- Decided: Mar 16, 2023 after 177 days
- Product code: OLU (Normalizing Quantitative Electroencephalograph Software)
- 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: 4 generations back to K801604 (1980). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171414: qEEG-Pro, Brainmaster Technologies, Inc. (2018) Summary page 4.

## Indications for use
The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.

Source page: https://510kreport.com/device/K222838
Methodology: https://510kreport.com/methodology