510(k) K252565
K252565 is an FDA 510(k) premarket notification submitted by Clouds of Care for the device "PreOp v3". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2026
- Date Received
- August 14, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization