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510(k) K100126

Device
STELLATE GRIDVIEW
Applicant
EXCEL-TECH LTD. (XLTEK)
510(k) number
K100126
Product code
OLX  
Decision
Substantially Equivalent (SESE)
Decision date
2010-12-03
Date received
2010-01-19
Regulation
882.1400
Classification name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Medical specialty
Neurology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GOLDY SINGH
Address
2568 Bristol Cir. Oakville CA L6H 5S1 L6H 5S1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OLX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252565PreOp v3Clouds of Care2026-02-13
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
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

Legacy Summary#

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FDA Review#

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