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510(k) K252565

Device
PreOp v3
Applicant
Clouds of Care
510(k) number
K252565
Product code
OLX
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-13
Date received
2025-08-14
Regulation
882.1400
Classification name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Gregor Strobbe
Address
Kliniekstraat 27a Ghent BE 9050 9050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250239NeuroMatchLVIS Corporation2025-05-23
K241513SourcererBrain Electrophysiology Laboratory Company, LLC2024-09-27
K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY2024-05-15
K210199RICOH MEGRicoh Company, Ltd.2021-07-02
K201910EZTrackNeurologic, LLC2020-12-22
K172858PreOpEpilog2018-01-08
K092844GEOSOURCEElectrical Geodesics, Inc.2010-12-21
K100126STELLATE GRIDVIEWExcel-Tech Ltd. (Xltek)2010-12-03
K091393ELEKTA NEUROMAG WITH MAXFILTERElekta Neuromag OY2010-10-26
K081430ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDINGElekta Neuromag OY2008-07-28
K070358MAXINSIGHTEemagine Medical Imaging Solutions GmbH2007-07-30
K050035ELEKTA NEUROMAG WITH MAXWELL FILTERElekta Neuromag OY2005-01-25
K041264ELEKTA OYElekta Neuromag OY2004-08-10
K040051MEGVISION, MODEL EQ1000C SERIESEagle Technology, Inc.2004-03-24
K030737OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275Ctf Systems (2001), Inc.2003-10-10