FDA.reportPublic FDA data

HeadPhones Slim

Primary DI
07090042053020
Brand
HeadPhones Slim
Company
Nordicneurolab AS
Model
HPS 1.0
Device description
Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Published
2016-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

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
K092253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092253000MODIFICATION TO FMRI HARDWARE SYSTEMNordicneurolab2009-10-08LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090042053020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090042053020070900420530207090042053020

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4755707095ProductSolutions@nordicneurolab.com

Regulatory Flags#

DUNS number
671280238
Device count
1
Lot or batch
true
Serial number
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
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
B66910031MRIaudioPREM1003MRIAUDIO, INC.LNH2026-03-31
B66910041MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
B66910051MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
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
00195278601162NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDLNH2025-04-15
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
B237ZXLADK600Zephyr Patient Positioning and Transfer SystemDiacor, Inc.LNH2023-06-08
10841962119402Applicator Clamp HolderQfixLNH2023-05-05