Atlas FDA

OLX

24 FDA 510(k) clearances · Product code

149 daysmedian time to decision
462 days90th percentile
24clearances measured

FDA profile

Official device name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Medical specialty
Neurology
Flags
Third-party review eligible
FDA definition
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
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RecordFirmDate
PreOp v3 (K252565)Clouds of Care2026-02-13
NeuroMatch (K250239)LVIS Corporation2025-05-23
Sourcerer (K241513)Brain Electrophysiology Laboratory Company, LLC2024-09-27
TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (K233985)Megin OY2024-05-15
RICOH MEG (K210199)Ricoh Company, Ltd.2021-07-02
EZTrack (K201910)Neurologic, LLC2020-12-22
PreOp (K172858)Epilog2018-01-08
GEOSOURCE (K092844)Electrical Geodesics, Inc.2010-12-21
STELLATE GRIDVIEW (K100126)Excel-Tech Ltd. (Xltek)2010-12-03
ELEKTA NEUROMAG WITH MAXFILTER (K091393)Elekta Neuromag OY2010-10-26
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (K081430)Elekta Neuromag OY2008-07-28
MAXINSIGHT (K070358)Eemagine Medical Imaging Solutions GmbH2007-07-30
ELEKTA NEUROMAG WITH MAXWELL FILTER (K050035)Elekta Neuromag OY2005-01-25
ELEKTA OY (K041264)Elekta Neuromag OY2004-08-10
MEGVISION, MODEL EQ1000C SERIES (K040051)Eagle Technology, Inc.2004-03-24
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 (K030737)Ctf Systems (2001), Inc.2003-10-10
NEUROSOFT'S SOURCE (K011241)Neurosoft, Inc.2001-09-19
CURRY MULTIMODAL NEUROIMAGING SOFTWARE (K001781)Neurosoft, Inc.2001-02-05
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG (K002631)Eemagine Medical Imaging Solutions GmbH2000-10-23
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG (K993708)Biomagnetic Technologies, Inc.1999-12-03
NEUROMAG VECTORVIEW (K984401)Philips Medical Systems (Cleveland), Inc.1998-12-30
IMAGE VUE EEG (K980477)Sam Technology, Inc.1998-08-06
MAGNES II BIOMAGNETOMETER (K941553)Biomagnetic Technologies, Inc.1996-05-16
700 SERIES BIOMAGNETOMETER (K901215)Biomagnetic Technologies, Inc.1990-06-25

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Every clearance here is in the API, with alerts when new ones post.