# K213900: WAVi SCAN EEG System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Wavi Co.
- Decided: May 6, 2022 after 143 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- 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: 10 generations back to K873535 (1987). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171781: eVox System, Evoke Neuroscience, Inc. (2017) Summary page 4.
- K143233: Mitsar-EEG, Mitsar Co., Ltd. (2015) Summary page 4.
- K141316: Cognision Eeg/EP System, Neuronetrix Solutions (2015) Summary page 4.

## Indications for use
WAVi SCAN EEG System is intended for the acquisition, display, and storage of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

Source page: https://510kreport.com/device/K213900
Methodology: https://510kreport.com/methodology