FDA.reportPublic FDA data

BrainView NeuralScan

Primary DI
08690020003062
Brand
BrainView NeuralScan
Company
Medeia, Inc.
Model
HW9N
Published
2025-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K192753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192753000NeuralScan SystemMedeia, Inc.2020-03-17GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08690020003062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08690020003062086900200030628690020003062

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
031827187
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08690020003017VitalScan ANSHW102025-02-05
08690020003024SudoCheckHW42025-02-05
08690020003031VitalScan HRVHW62025-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
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
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B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
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B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25