FDA.reportPublic FDA data

MaxFilter™ 2.2

Primary DI
06430056480046
Brand
MaxFilter™ 2.2
Company
Megin Oy
Model
SW25613N
Device description
MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo in suppressing magnetic interference and in reducing measurement artifacts.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLYMagnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLYMagnetoencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091393000ELEKTA NEUROMAG WITH MAXFILTERElekta Neuromag OY2010-10-26OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480046064300564800466430056480046

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

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
06430056480404MEGreview™SW26241N2025-05-23
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
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
06430056480039MaxFilter™ 2.2Megin OyOLY2025-05-23
06430056480404MEGreview™Megin OyOLY2025-05-23
06430056480411TRIUX™ neoMegin OyOLY2025-05-23
06430056480428Finger response padMegin OyOLY2025-04-11
B956CO0275110CTF MEGCTF MEG International Services Limited PartnershipOLY2020-12-01
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
0643005648011432-channel EEG cap (S)Megin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480053Patient chairMegin OyOLY2016-09-23
06430056480060Patient couch Megin OyOLY2016-09-23
06430056480077Child insert for chairMegin OyOLY2016-09-23
06430056480084Auditory stimulator (earphones)Megin OyOLY2016-09-23
06430056480091Bilateral finger response systemMegin OyOLY2016-09-23
06430056480107Head position coil setMegin OyOLY2016-09-23
0643005648019032-channel EEG cap (S)Elekta OyOLY2016-09-23
0643005648012132-channel EEG cap (M)Megin OyOLY2016-09-23
0643005648013832-channel EEG cap (L)Megin OyOLY2016-09-23
0643005648014564-channel EEG cap (S)Megin OyOLY2016-09-23
0643005648015264-channel EEG cap (M)Megin OyOLY2016-09-23
0643005648016964-channel EEG cap (L)Megin OyOLY2016-09-23
06430056480176128-channel EEG cap (M)Megin OyOLY2016-09-23
06430056480183128-channel EEG cap (L)Megin OyOLY2016-09-23
06430056480275EEG Cap adaptorMegin OyOLY2016-09-23
06430056480282SEF electrode assemblyMegin OyOLY2016-09-23