# K260563: CN-Suite™

- Pathway: 510(k) (Traditional)
- Applicant: FIND Surgical Sciences Inc. D/B/A FIND Neuro
- Decided: Aug 16, 2026 after 178 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: 8 generations back to K901215 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201910: EZTrack, Neurologic, LLC (2020) Summary page 6.
- K233985: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B), Megin OY (2024) Summary page 6.

## Indications for use
The CN-Suite™ is intended for use by trained and qualified clinicians (e.g., EEG technologists, epileptologists, and neurosurgeons) on adult and pediatric patients (aged 3 years and older) with focal or multifocal epilepsy for the visualization and quantitative analysis of brain network dynamics derived from intracranial electrophysiological recordings (iEEG). CN-Suite™ calculates and displays patient-specific Criticality Values for each analysis node. Criticality Values are continuous quantitative metrics derived from delay-adjusted, non-linear directed causality analysis of spatiotemporal electrophysiological patterns and are intended to assist trained clinicians in identifying and prioritizing brain regions that may be relevant during presurgical evaluation. Device outputs are intended to be interpreted in conjunction with the original electrophysiological recordings, neuroimaging data, and other available clinical information. CN-Suite™ provides quantitative clinical decision-support information and does not provide autonomous diagnostic conclusions or treatment recommendations. The software does not independently determine the epileptogenic zone or recommend surgical intervention. Device outputs are intended to support, but not replace, multidisciplinary clinical judgment and should always be interpreted together with other available clinical information.

Source page: https://510kreport.com/device/K260563
Methodology: https://510kreport.com/methodology