FDA.reportPublic FDA data

Eye Tracker Camera

Primary DI
07090042052023
Brand
Eye Tracker Camera
Company
Nordicneurolab AS
Model
ETC 2.0
Published
2017-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07090042052023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07090042052023070900420520237090042052023

GMDN Terms#

Term, Definition table
TermDefinition
Vision physiology/eye movement analysis systemAn electronic unit or device assembly intended to measure, record, and display a range of ophthalmic parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation; it is neither intended to measure dimensional/ocular-shape parameters nor is it dedicated to neurological assessment. Features may include visual stimuli (e.g., light/image patterns) and/or sensing/tracking devices (e.g., bioelectric amplifiers, cameras).

Contacts#

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

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
false
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 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
07090042053013HeadphonesHP 1.32016-09-24
07090042053044CommunicationConsoleCC 2.32016-10-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00195278601162NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDLNH2025-04-15
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09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19
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