/ EN
2026-08-16 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears FIND Neuro CN-Suite Localization Tool

Summary The US Food and Drug Administration cleared CN-Suite, source localization software from FIND Surgical Sciences Inc., doing business as FIND Neuro, on August 16, 2026, finding it substantially equivalent under submission number K260563 via the Traditional 510(k) pathway. FDA lists the device as Source Localization Software for Electroencephalograph or Magnetoencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Such software works back from electrical or magnetic fields recorded at the scalp to the intracranial origin of the signal, supporting presurgical planning such as locating epileptic foci.
Why it matters A date-anchored regulatory record: the K number, decision date and device classification together fix how FDA currently treats source localization software, a baseline for comparing later clearances on the same pathway.

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.

Compiled by BCIwiki from public sources

Sources · 1
Read original ↗
Suggest a correction Revisions · none / EN
© 2026 BCIwiki.com Digest Topics Tips Subscribe Revisions About