Cleared Special

PreOp v3

K252565 · Clouds of Care · Neurology
Feb 2026
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K252565 is an FDA 510(k) clearance for the PreOp v3, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Clouds of Care (Ghent, BE). The FDA issued a Cleared decision on February 13, 2026, 183 days after receiving the submission on August 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K252565 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2025
Decision Date February 13, 2026
Days to Decision 183 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization