FDA.reportPublic FDA data

HeadSet 1,5T

Primary DI
07090042053112
Brand
HeadSet 1,5T
Company
Nordicneurolab AS
Model
1.0
Device description
nordicAudio is an audio system for use in MR. The HeadSet is an MR compatible Headset to play audio during MR examination.
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251937000nordicAudio (1.0)Nordicneurolab AS2026-03-20LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090042053112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090042053112070900420531127090042053112

GMDN Terms#

Term, Definition table
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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07090042053051BatteryBox1.02026-04-01
07090042053068HeadSet 3T1.02026-04-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19