FDA.reportPublic FDA data

NeuroMatch

Primary DI
00850056774017
Brand
NeuroMatch
Company
LVIS CORPORATION
Model
1.0.7
Device description
NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
OMAAmplitude-Integrated Electroencephalograph
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLXSource Localization Software For Electroencephalograph Or MagnetoencephalographNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222450000
K241390000
K250239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222450000LVIS NeuroMatchLVIS Corporation2023-06-09OMB
K241390000NeuroMatchLVIS Corporation2024-11-26OMB
K250239000NeuroMatchLVIS Corporation2025-05-23OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056774017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056774017008500567740178500567740170850056774017

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic diagnosis-support softwareA software program intended to acquire and process neurological physiological parameter data [primarily electroencephalographic (EEG)] to assist a healthcare professional in the diagnosis of neurological conditions. It has a general-purpose neurological use and is not dedicated to, e.g., sleep monitoring, psychiatric analysis, or seizure-detection.

Regulatory Flags#

DUNS number
079120302
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056774000NeuroMatch1.0.42025-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.OLT2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAOLT2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAOLT2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAOLT2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAOLT2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28