# K201910: EZTrack

- Pathway: 510(k) (Traditional)
- Applicant: Neurologic, LLC
- Decided: Dec 22, 2020 after 166 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: 1 generation back to K182181 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182181: Persyst 14 EEG Review and Analysis Software, Persyst Development Corporation (2018) Summary page 5.

## Most influential descendants
- K260563: CN-Suite™ (2026), 0 descendants of its own

## Indications for use
EZTrack is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects with focal or multifocal epilepsy at least 3 years of age for the visualization of human brain function from analysis of electroencephalographic (EEG) signals produced by electrically active tissue of the brain. EZTrack calculates and displays the Fragility Index, a quantitative index based on an analysis of spatiotemporal EEG patterns that is intended for interpretation by trained physicians to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient’s condition to the user and should be interpreted along with other clinical data, including the original EEG, medical imaging, and other standard neurological and neuropsychological assessments.

Source page: https://510kreport.com/device/K201910
Methodology: https://510kreport.com/methodology