BCIwiki (bciwiki.com) — FIND Surgical Sciences Inc. D/B/A FIND Neuro received an FDA 510(k) decision of Substantially Equivalent for CN-Suite on August 16, 2026, under submission number K260563. The submission followed the Traditional 510(k) clearance pathway.
FDA lists the product under the device classification name Source Localization Software For Electroencephalograph Or Magnetoencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Source localization software infers the intracranial origin of signals from scalp-recorded fields, supporting presurgical planning such as localization of epileptic foci.