# K143233: Mitsar-EEG

- Pathway: 510(k) (Traditional)
- Applicant: Mitsar Co., Ltd.
- Decided: Aug 13, 2015 after 276 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: 2 generations back to K964280 (1997). 4 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061908: Nicoletone System V32 Amplifier, Viasys Neuro Care (2006) Summary page 4.
- K946094: Cadwell Easy Ambulatory Eeg, Cadwell Laboratories, Inc. (1995) Summary page 5.

## Most influential descendants
- K171781: eVox System (2017), 6 descendants of its own
- K192753: NeuralScan System (2020), 3 descendants of its own
- K221963: Cumulus Functional Neurophysiology Platform (2023), 1 descendant of its own
- K170441: ElectroTek (2017), 1 descendant of its own
- K253767: UB ERP System (2026), 0 descendants of its own

## Indications for use
The Mitsar-EEG is intended to acquire, display and store the electrical activity of a patient's brain obtained by placing two or more electrodes on the head to aid in diagnosis.

Source page: https://510kreport.com/device/K143233
Methodology: https://510kreport.com/methodology