FDA.reportPublic FDA data

MEGreview™

Primary DI
06430056480404
Brand
MEGreview™
Company
Megin Oy
Model
SW26241N
Device description
MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex,such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.
Published
2025-05-23
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
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
OLYMagnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLXSource Localization Software For Electroencephalograph Or MagnetoencephalographNeurology2
OLYMagnetoencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233985000TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY2024-05-15OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480404064300564804046430056480404

GMDN Terms#

Term, Definition table
TermDefinition
Magnetoencephalography system, superconductingAn assembly of devices intended to be used to noninvasively detect, measure, and display bio-magnetic signals produced by electrically-active brain tissue, and to provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy [magnetoencephalography (MEG)]. It consists of a movable gantry, patient support apparatus, dewar [vessel containing liquid helium (He)], dedicated software, and a superconducting quantum interference device (SQUID) sensor array that measures the magnetic fields created by neuronal electrical currents. It is typically sited within a magnetically-shielded room (MSR).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
538025107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430056480428Finger response padNM20928X2025-04-11
06430056480008Elekta Neuromag® TRIUXNM23900N2016-09-23
06430056480381TRIUX™ neo couchNM25906N 2018-04-30
06430056480039MaxFilter™ 2.2SW24051N2025-05-23
06430056480411TRIUX™ neoNM27000N2025-05-23
06430056480343HPI coil set (VectorView)NM20555XNM20555N2016-09-23
0643005648029960-channel cap (S)NM20885N2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
06430056480329124-channel cap (M)NM21302N2016-09-23
06430056480336Auditory stimulator earphones (VectorView)EL21103J2016-09-23
0643005648011432-channel EEG cap (S)NM24430NNM23905N2016-09-23
0643005648012132-channel EEG cap (M)NM24431NNM23906N2016-09-23
0643005648013832-channel EEG cap (L)NM24432NNM23907N2016-09-23
06430056480015Elekta Neuromag® TRIUXNM25000N2016-09-23
06430056480022Data analysis software 3.4SW23380N2016-09-23
06430056480046MaxFilter™ 2.2SW25613N2016-09-23
06430056480053Patient chairNM23124N2016-09-23
06430056480060Patient couch NM23125N2016-09-23
06430056480077Child insert for chairBC20899N2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOLX2026-05-12
05430000733038Persyst ESI powered by EpilogClouds of CareOLX2026-04-20
09342451002433Compumedics CurryCOMPUMEDICS LIMITEDOLX2026-03-12
00860008953100SourcererBrain Electrophysiology Laboratory Company, LLCOLX2025-10-20
06430056480039MaxFilter™ 2.2Megin OyOLY2025-05-23
06430056480411TRIUX™ neoMegin OyOLX2025-05-23
06430056480411TRIUX™ neoMegin OyOLY2025-05-23
06430056480428Finger response padMegin OyOLY2025-04-11
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOLX2023-07-24
05430000733045Persyst ESI powered by EpilogClouds of CareOLX2023-06-14
05430000733021PreOpClouds of CareOLX2022-06-22
00850033571028GeoSource 2.0 Source Estimation SoftwareMagstim, Inc.OLX2022-01-25
B956CO0275110CTF MEGCTF MEG International Services Limited PartnershipOLY2020-12-01
05430000733007PreOp Clouds of CareOLX2020-10-01
06430056480374TRIUX™ neo chairMegin OyOLY2018-04-30
06430056480381TRIUX™ neo couchMegin OyOLY2018-04-30
06430056480398TRIUX™ neoMegin OyOLY2018-04-30
06430056480367Pediatric comfort setMegin OyOLY2018-04-10
04961311926266RICOH MEGRICOH COMPANY,LTD.OLY2018-03-07
04961311926266RICOH MEGRICOH COMPANY,LTD.OLX2018-03-07
00863003000343GeoSourceELECTRICAL GEODESICS, INC.OLX2016-10-04
0643005648011432-channel EEG cap (S)Megin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480022Data analysis software 3.4Megin OyOLX2016-09-23
06430056480046MaxFilter™ 2.2Megin OyOLY2016-09-23
06430056480053Patient chairMegin OyOLY2016-09-23
06430056480060Patient couch Megin OyOLY2016-09-23