FDA.reportPublic FDA data

CTF MEG

Primary DI
B956CO0275110
Brand
CTF MEG
Company
CTF MEG International Services Limited Partnership
Model
CTF MEG 275
Catalog number
CO-0275-1-1
Device description
Magnetoencephalography system (MEG), 275 channel
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLYMagnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLYMagnetoencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030737000OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275Ctf Systems (2001), Inc.2003-10-10OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B956CO0275110PrimaryHIBCC0

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203364765
Device count
1
Serial number
true

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
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
06430056480046MaxFilter™ 2.2Megin 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