PreOp v3— 510(k) K252565
Substantially EquivalentClouds of Care
FDA 510(k) clearance K252565 for PreOp v3, Substantially Equivalent on 2026-02-13. Applicant: Clouds of Care. Device class: 2.
Summary
Clouds of Care's PreOp v3 is filed under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Special 510(k).
Clouds of Care filed from Ghent, Belgium. The substantially equivalent decision came 183 calendar days after receipt (August 14, 2025 to February 13, 2026).
Clearance details
- Applicant
- Clouds of Care
- Product code
- Product code OLX
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ghent, BE
Recent devices under product code OLX
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