FDA.reportPublic FDA data

NeuroFlex

Primary DI
G676NEUROFLEX0
Brand
NeuroFlex
Company
Saccade Analytiques Inc
Model
NeuroFlex
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PTYComputerized Cognitive Assessment Aid, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTYComputerized Cognitive Assessment Aid, ExemptNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G676NEUROFLEX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye-tracking neurological/brain injury assessment deviceAn electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203752451
Device count
1
Premarket exempt
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770027067016MSCopilot®AD SCIENTIAMPTY2026-04-20
07290016986198XRCogni XR HEALTH IL LTDPTY2026-02-12
00860013886127CNS Vital Signs VSCCNS Vital Signs, LLCPTY2025-09-01
05070002974673NeuroMotor PenMANUS NEURODYNAMICA LTDPTY2025-08-01
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.PTY2025-07-18
00860013886103CNS Vital Signs WebCNS Vital Signs, LLCPTY2025-07-07
00860013886110CNS Vital Signs LocalCNS Vital Signs, LLCPTY2025-07-07
00860013886134CNS Vital Signs CognitraxCNS Vital Signs, LLCPTY2025-07-07
00860000564045Cognivue ClarityCOGNIVUE, INC.PTY2025-06-12
00860000564052Cognivue ThriveCOGNIVUE, INC.PTY2025-06-12
00860011882022SPARK NeuroSpark Neuro Inc.PTY2025-05-01
04262390860015neotivCareneotiv GmbHPTY2025-04-14
G134EPIO1NeuroCatch EPiONeuroCatch IncPTY2025-02-28
00860011464525CognigramCogstate Inc.PTY2025-01-18
00860011464532CognigramCogstate Inc.PTY2025-01-18
G134NCCPXS1NeuroCatch EEG CapNeuroCatch IncPTY2024-12-01
00860011464501CognigramCogstate Inc.PTY2024-08-24
00860011464518CognigramCogstate Inc.PTY2024-08-24
00860007318764Cognition Chronicle v2.1Qr8 Health IncPTY2024-07-22
B626200050Core Cognitive EvaluationLinus Health, Inc.PTY2024-06-05
00860007318788Chronicle Web v2.0Qr8 Health IncPTY2024-05-20
00860007318795Cognition Chronicle v2.0Qr8 Health IncPTY2024-05-20
00860011850922Cognition Snapshot+ v2.4Qr8 Health IncPTY2024-04-29
00860011850908MSPT v3.1.1Qr8 Health IncPTY2024-04-05
00860011850915MSPT Web v3.1.0Qr8 Health IncPTY2024-04-05
00195893329458MSPT Web v3.0Qr8 Health IncPTY2024-03-01
00195893702190MSPT v3.0Qr8 Health IncPTY2024-02-16
00860011154501BrainCheck AssessBraincheck, Inc.PTY2023-12-15
00860007318771Cognition Snapshot+ 2.3.0Qr8 Health IncPTY2023-11-01
00860009958104Cognitive Assessment Battery (CAB)® PROCognifit, Inc.PTY2023-08-14