FDA.report

HeadSet 3T

Primary DI
07090042053068
Brand
HeadSet 3T
Company
Nordicneurolab AS
Model
1.0
Device description
nordicAudio is an audio system for use in MR, consisting of a HeadSet with BatteryBox and an AccessPoint in the MR Room. An AudioHub and a BatteryCharger is placed in the operator room.
Published
2026-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications

CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions

SubmissionSupplement
K251937000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251937000nordicAudio (1.0)Nordicneurolab AS2026-03-20LNH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07090042053068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07090042053068070900420530687090042053068

GMDN Terms

TermDefinition
Patient audiovisual communication/entertainment systemAn assembly of devices intended to be used to provide a communication and/or entertainment channel for a patient undergoing a radiological examination (e.g., MRI scan). It typically consists of a control unit, intercom, and data communication hub; with earplugs, or other personal audio device, and/or a visual monitor for the patient. It may be supplied in a modular fashion.

Regulatory Flags

DUNS number
671280238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07090042053051BatteryBox1.02026-04-01
07090042053075BatteryCharger1.02026-04-01
07090042053082AccessPoint1.02026-04-01
07090042053099AudioHub1.02026-04-01
07090042052122Visual System Power SupplyVPS-1.22025-04-04
07090042059053nordicDSC23.042024-02-12
07090042052078VisualSystem Power Cable (VPC)1.12021-01-29
07090042052108Visual System HDVHD-1.22021-01-29
07090042052061Control Room InterfaceCRI-1.02020-03-01
07090042052085Visual System HDVHD-1.12020-03-01
07090042052092Visual System Power SupplyVPS-1.12020-03-01
07090042054041ResponseGrip InterfaceRGI-2.22019-10-24
07090042054058SyncBoxSB- 3.22019-10-24
07090042051057LCD Power SupplyLPS-3.12019-06-27
07090042051033Inroom Viewing DeviceLDC 3.02016-09-24
07090042051040LCD Power SupplyLPS 3.02016-09-24
07090042052016Coil Mounted DisplayCMD 2.32016-09-24
07090042052023Eye Tracker CameraETC 2.02017-12-31
07090042053013HeadphonesHP 1.32016-09-24
07090042053044CommunicationConsoleCC 2.32016-10-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04573596200865APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200889APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200896APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200902APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200940APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200964APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200971APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201480APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201497APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201503APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202210APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202227APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
07090042053051BatteryBoxNordicneurolab ASLNH2026-04-01
07090042053075BatteryChargerNordicneurolab ASLNH2026-04-01
07090042053082AccessPointNordicneurolab ASLNH2026-04-01
07090042053099AudioHubNordicneurolab ASLNH2026-04-01
00857534006929Neuro II-SEIMRIS Imaging, Inc.LNH2026-03-20
B66910103G TransducerMRIAUDIO, INC.LNH2026-03-06
B6693300MRIaudio Over-Ear HeadphonesMRIAUDIO, INC.LNH2026-03-06
B66915070MRIaudioMRIAUDIO, INC.LNH2026-03-03
04068151995268MAGNETOM LuminaSiemens Healthineers AGLNH2026-02-23
04068151995312MAGNETOM Sola FitSiemens Healthineers AGLNH2026-02-23
00884838104402IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-27
04056869299594MAGNETOM Flow.NeoSiemens Healthcare GmbHLNH2026-01-19
04068151034196MAGNETOM Flow.EliteSiemens Healthcare GmbHLNH2026-01-19
00884838128415Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128422Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128439Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128446Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128453Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07