2026-02-13 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears PreOp v3 Source Localization Tool

Summary The FDA cleared Clouds of Care's PreOp v3 on February 13, 2026, finding it substantially equivalent under submission number K252565 through the special 510(k) pathway. The agency classifies it as Source Localization Software for Electroencephalograph or Magnetoencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Source localization software infers the intracranial origin of signals from scalp-recorded electric or magnetic fields, a step in neurosurgical planning such as presurgical localization of epileptic foci.

Why it matters Presurgical epilepsy planning is one of the few settings where a scalp-derived source estimate is later checked against what surgeons find inside the skull, which makes cleared localization software a useful reference point for how far noninvasive spatial resolution can be pushed.

BCIwiki (bciwiki.com) — Clouds of Care received an FDA 510(k) decision of Substantially Equivalent for PreOp v3 on February 13, 2026, under submission number K252565. The submission followed the Special 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 electric or magnetic fields, a step in neurosurgical planning such as presurgical localization of epileptic foci.

Compiled by BCIwiki from public sources

Sources · 1

accessdata.fda.gov 2026-02-13

Epilepsy EEG United States

Read original ↗

Suggest a correction Revisions · none 中 / EN