FDA.reportPublic FDA data

Cognitive assessment software

Definition
A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.
GUDID devices
49
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860009484504Neurotrack Cognitive Assessment BatteryNeurotrack Technologies, Inc.1.1.02022-12-15
00868168000306SwayHEALTHY ROSTER LLCSway Sports Plus2026-04-13
05070002974673NeuroMotor PenMANUS NEURODYNAMICA LTDNMP-P32025-08-01
00860000564045Cognivue ClarityCOGNIVUE, INC.Portable Device Model 22025-06-12
00860000564052Cognivue ThriveCOGNIVUE, INC.Portable Device Model 22025-06-12
00860011882022SPARK NeuroSpark Neuro Inc. SP0100002025-05-01
04262390860015neotivCareneotiv GmbH1.0.02025-04-14
00860007318764Cognition Chronicle v2.1Qr8 Health IncCHR-COG-212024-07-22
B626200050Core Cognitive EvaluationLinus Health, Inc.200052024-06-05
00860007318788Chronicle Web v2.0Qr8 Health IncCHR-COG-W202024-05-20
00860007318795Cognition Chronicle v2.0Qr8 Health IncCHR-COG-202024-05-20
00860011850922Cognition Snapshot+ v2.4Qr8 Health IncSNP-COG-242024-04-29
00860011850908MSPT v3.1.1Qr8 Health IncMSPT-3112024-04-05
00860011850915MSPT Web v3.1.0Qr8 Health IncMSPT-W3102024-04-05
00195893329458MSPT Web v3.0Qr8 Health IncMSPT-W302024-03-01
00195893702190MSPT v3.0Qr8 Health IncMSPT-302024-02-16
00860011154501BrainCheck AssessBraincheck, Inc.22023-12-15
00860007318771Cognition Snapshot+ 2.3.0Qr8 Health IncSNP-COG-232023-11-01
00860009693401Speech Vitals - CognitionAural Analytics, Inc.SVCOG2022-12-15
00860011042105DANA™Anthrotronix, Inc.1.02023-10-09
00860009958104Cognitive Assessment Battery (CAB)® PROCognifit, Inc.PRO2023-08-14
G527GTDHIPALPRO01V1010HiPAL ProGT DIAGNOSTICS (UK) LIMITED1.0.12023-07-28
00860007318757Cognition Snapshot+ 2.2.0Qr8 Health IncSNP-COG-222023-05-22
00196852685837Speech Vitals - CognitionAural Analytics, Inc.SDK2022-11-07
B626200020Research PlatformLinus Health, Inc.200022022-09-03
B626200010Core Cognitive Evaluation Linus Health, Inc.200012022-06-28
00860007318726Chronicle WebQr8 Health IncCHR-COG-W102022-02-11
00860007318733Cognition ChronicleQr8 Health IncCHR-COG-102022-02-11
00860007318740Cognition Snapshot+ 2.1.0Qr8 Health IncSNP-GOG-212021-11-12
00884838108554INTELLISPACE™ COGNITIONPhilips Electronics Nederland B.V.6.0.x.x2021-10-04
00860007318719Cognition Snapshot v2.0Qr8 Health IncSNP-COG-202021-09-02
00860007318702Cognition SnapshotQr8 Health IncSNP-COG-102021-07-22
00884838104587INTELLISPACE™ COGNITIONPhilips Electronics Nederland B.V.5.0.x.x2021-06-02
00864127000356ImPACT Quick TestIMPACT APPLICATIONS, INC.22021-03-05
00864127000349ImPACT Version 4IMPACT APPLICATIONS, INC.42021-02-27
00884838103900INTELLISPACE™ COGNITIONPhilips Electronics Nederland B.V.4.0.x.x2021-01-28
00864127000332Cognitive Impairment ScreenerIMPACT APPLICATIONS, INC.12020-12-16
00884838103535INTELLISPACE™ COGNITIONPhilips Electronics Nederland B.V.3.0.x.x2020-10-01
00884838101036INTELLISPACE™ COGNITION Philips Electronics Nederland B.V.2.0.x.x2020-05-19
00860000564007Cognivue Advanced with CartCOGNIVUE, INC.Cart Unit2020-04-10
00860000564014Cognivue Advanced DesktopCOGNIVUE, INC.Desktop Unit2020-04-10
00860000564021Cognivue ClarityCOGNIVUE, INC.Portable Device2020-04-10
00860000564038Cognivue ThriveCOGNIVUE, INC.Portable Device2020-04-10
00862290000302T.O.V.A.TOVA COMPANY, THEUSB Device2020-01-02
00862290000319T.O.V.A.TOVA COMPANY, THEMicroswitch2020-01-02
00862290000326T.O.V.A.TOVA COMPANY, THESoftware2020-01-02
00862290000333T.O.V.A.TOVA COMPANY, THEKit2020-01-02
00884838098244INTELLISPACE™ COGNITIONPhilips Electronics Nederland B.V.1.1.X2019-10-30
00860000709408Brain Gauge MDCORTICAL METRICS, LLC1.02018-11-27