FDA.reportPublic FDA data

WAVi Scan Software

Primary DI
B592SW100
Brand
WAVi Scan Software
Company
WAVI CO.
Model
SW100
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response
GWQFull-Montage Standard Electroencephalograph
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213900000WAVi SCAN EEG System and AccessoriesWavi Co.2022-05-06GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B592SW100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
007785282
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B592WD100WAVi Electrical Processing UnitWD1002026-03-25
B592WH801WAVi Style Ear ClipsWH8012026-03-25
B592WK200WAVi Scan KitWK2002026-03-25
B592WE100WAVi Co.WE1002019-03-11
B592WE200WAVi Co.WE2002019-03-11
B592WH200WAVi CoWH2002019-03-11
B592WH300WAVi Co.WH3002019-03-11
B592WH400WAVi Co.WH4002019-03-11
B592WH500WAVi Co.WH5002019-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.OLT2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22