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73 devices · 54 companies · 2014 to 2026

AI-enabled neurology devices on FDA's list

73 devices in the Neurology panel, 2014 to 2026, from 54 companies across 20 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (73 of 73 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes in the Neurology panel

Companies with more than one device here

Every device, newest decision first

Neurology · 73 devices
DecisionDeviceCompanyProduct codeFDA
SOMNUMK253390 · 510(k)Honeynaps Co., Ltd.OLZdatabase entry
MeRT SystemK260402 · 510(k)Wave NeuroscienceSIGdatabase entry
myosmart.K253256 · 510(k)Otto Bock Healthcare Products GmbHGXYdatabase entry
Stealth AXiS Cranial clinical applicationK253379 · 510(k)Medtronic Navigation, Inc.HAWdatabase entry
Onera SleepMapK253668 · 510(k)Onera B.V.OLZdatabase entry
EarliPoint AssessmentK253442 · 510(k)Earlitec DiagnosticsQPFdatabase entry
Stealth AXiS Surgical System with Stealth AXiS SK253381 · 510(k)Medtronic Navigation, Inc.OLOdatabase entry
SafeOp 3: Neural Informatix SystemK252842 · 510(k)Alphatec Spine, Inc.GWFdatabase entry
Ceribell Delirium Monitor SystemK251936 · 510(k)Ceribell, Inc.NCGdatabase entry
NelliK251506 · 510(k)Neuro Event Labs OYPOSdatabase entry
DeepRESPK252330 · 510(k)Nox Medical EhfOLZdatabase entry
xvision Spine systemK251639 · 510(k)Augmedics, Ltd.SBFdatabase entry
SpineAR SNAPK252054 · 510(k)Surgical Theater, Inc.SBFdatabase entry
Mazor X System / Mazor X Stealth EditionK251316 · 510(k)Mazor Robotics Ltd.OLOdatabase entry
Felix NeuroAI SystemK250096 · 510(k)Fasikl IncorporatedQBCdatabase entry
TMINI Miniature Robotic SystemK250877 · 510(k)THINK Surgical, Inc.OLOdatabase entry
EpiMonitorK250515 · 510(k)Empatica SrlPOSdatabase entry
OTS HipK250086 · 510(k)Ortoma ABOLOdatabase entry
Canvas DxK243558 · 510(k)Cognoa, Inc.QPFdatabase entry
autoSCOREK243743 · 510(k)Holberg EEG ASOMBdatabase entry
EarliPoint SystemK243891 · 510(k)EarliTec DiagnosticsQPFdatabase entry
DeepRESPK241960 · 510(k)Nox Medical ehfOLZdatabase entry
xvision Spine systemK250255 · 510(k)Augmedics Ltd.SBFdatabase entry
Falcon HSTK242447 · 510(k)Compumedics LimitedOLVdatabase entry
ClearPoint SystemK243657 · 510(k)ClearPoint Neuro, Inc.HAWdatabase entry
ARVIS ShoulderK243950 · 510(k)Kico Knee Innovation Company Pty LtdSBFdatabase entry
TMINI Miniature Robotic SystemK243481 · 510(k)THINK Surgical, Inc.OLOdatabase entry
FLASH EVD SystemK242480 · 510(k)7D Surgical ULCHAWdatabase entry
NeuroMatchK241390 · 510(k)LVIS CorporationOMBdatabase entry
Dreem 3SK242094 · 510(k)Beacon Biosignals, Inc.OLZdatabase entry
REMI-AI Rapid Detection ModuleK240408 · 510(k)Epitel, IncOMBdatabase entry
xvision Spine SystemK241481 · 510(k)Augmedics Ltd.SBFdatabase entry
encevisK240993 · 510(k)AIT Austrian Institute of Technology GmbHOMBdatabase entry
ARVIS ShoulderK240062 · 510(k)Insight Medical Systems, Inc.OLOdatabase entry
Oxevision Sleep DeviceK233618 · 510(k)Oxehealth LimitedLELdatabase entry
Automatic RegistrationK234047 · 510(k)Brainlab AGOLOdatabase entry
OTS HipK232140 · 510(k)Ortoma ABOLOdatabase entry
SleepStageMLK233438 · 510(k)Beacon Biosignals, Inc.OLZdatabase entry
EpiMonitorK232915 · 510(k)Empatica SrlPOSdatabase entry
BrainSeeDEN220066 · De NovoDarmiyan, Inc.QWTdatabase entry
autoSCOREK231068 · 510(k)Holberg EEG ASOMBdatabase entry
REMI AI Discrete Detection ModuleK231779 · 510(k)Epitel, Inc.OMBdatabase entry
ClearPoint SystemK233243 · 510(k)ClearPoint Neuro Inc.HAWdatabase entry
Alignment System Cranial, Alignment Software CraK223864 · 510(k)Brainlab AGHAWdatabase entry
Dreem 3SK223539 · 510(k)Beacon Biosignals, Inc.OLZdatabase entry
Spine PlanningK223553 · 510(k)Brainlab AGOLOdatabase entry
Cranial Navigation, Navigation Software Cranial,K223288 · 510(k)Brainlab AGHAWdatabase entry
EarliPointK230337 · 510(k)EarliTec Diagnostics, IncQPFdatabase entry
Ceribell Status Epilepticus MonitorK223504 · 510(k)Ceribell, Inc.OMBdatabase entry
ENT EMK223734 · 510(k)Brainlab AGPGWdatabase entry
Brainlab Elements – Trajectory PlanningK223552 · 510(k)Brainlab AGHAWdatabase entry
NeuroRPMK221772 · 510(k)New Touch Digital Inc.GYDdatabase entry
Alpha Control Liner SystemK223738 · 510(k)CoaptGXYdatabase entry
SomnoMetryK221179 · 510(k)Neumetry Medical IncOLZdatabase entry
EarliPoint SystemK213882 · 510(k)EarliTec Diagnostics, Inc.QPFdatabase entry
EYE-SYNCK202927 · 510(k)SyncThink, Inc.QEAdatabase entry
EnsoSleepK210034 · 510(k)EnsoData, Inc.OLZdatabase entry
Cognoa ASD Diagnosis AidDEN200069 · De NovoCognoa, Inc.QPFdatabase entry
EyeBOXK201841 · 510(k)Oculogica, Inc.QEAdatabase entry
7D Surgical System Cranial Biopsy and VentriculaK192945 · 510(k)7D Surgical Inc.HAWdatabase entry
BrainScope TBIK190815 · 510(k)BrainScope Company, Inc.PIWdatabase entry
Myo PlusK191179 · 510(k)Otto Bock Healthcare Products GmbHGXYdatabase entry
EyeBOXK191183 · 510(k)Oculogica, Inc.QEAdatabase entry
COMPLETE CONTROL System Gen2K191083 · 510(k)Coapt, LLCGXYdatabase entry
EyeBOXDEN170091 · De NovoOculogica, Inc.QEAdatabase entry
EmbraceK181861 · 510(k)Empatica SrlPOSdatabase entry
Persyst 14 EEG Review and Analysis SoftwareK182181 · 510(k)Persyst Development CorporationOMBdatabase entry
Sense System with IBT ElectrodesK182112 · 510(k)Infinite Biomedical Technologies, LLCGXYdatabase entry
RightEye Vision SystemK181771 · 510(k)RightEye, LLCGWNdatabase entry
NuVasive Pulse SystemK180038 · 510(k)NuVasive, IncorporatedOLOdatabase entry
Ahead 300K161068 · 510(k)BRAINSCOPE COMPANY INCPIWdatabase entry
Brainscope Ahead 200K143643 · 510(k)BRAINSCOPE COMPANY, INC.PIWdatabase entry
BrainScope Ahead 100DEN140025 · De NovoBRAINSCOPE COMPANY, INCPIWdatabase entry

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