FDA.reportPublic FDA data

Cognition Chronicle v2.1

Primary DI
00860007318764
Brand
Cognition Chronicle v2.1
Company
Qr8 Health Inc
Model
CHR-COG-21
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00860007318764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007318764008600073187648600073187640860007318764

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive assessment softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080506730
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
00860007318788Chronicle Web v2.0CHR-COG-W202024-05-20
00860007318795Cognition Chronicle v2.0CHR-COG-202024-05-20
00860011850922Cognition Snapshot+ v2.4SNP-COG-242024-04-29
00860011850908MSPT v3.1.1MSPT-3112024-04-05
00860011850915MSPT Web v3.1.0MSPT-W3102024-04-05
00195893329458MSPT Web v3.0MSPT-W302024-03-01
00195893702190MSPT v3.0MSPT-302024-02-16
00860007318771Cognition Snapshot+ 2.3.0SNP-COG-232023-11-01
00860007318757Cognition Snapshot+ 2.2.0SNP-COG-222023-05-22
00860007318726Chronicle WebCHR-COG-W102022-02-11
00860007318733Cognition ChronicleCHR-COG-102022-02-11
00860007318740Cognition Snapshot+ 2.1.0SNP-GOG-212021-11-12
00860007318719Cognition Snapshot v2.0SNP-COG-202021-09-02
00860007318702Cognition SnapshotSNP-COG-102021-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013886127CNS Vital Signs VSCCNS Vital Signs, LLCPTY2025-09-01
05070002974673NeuroMotor PenMANUS NEURODYNAMICA LTDPTY2025-08-01
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
G676NEUROFLEX0NeuroFlexSaccade Analytiques IncPTY2025-04-29
04262390860015neotivCareneotiv GmbHPTY2025-04-14
G134EPIO1NeuroCatch EPiONeuroCatch IncPTY2025-02-28
G134NCCPXS1NeuroCatch EEG CapNeuroCatch IncPTY2024-12-01
00860011464501CognigramCogstate Inc.PTY2024-08-24
00860011464518CognigramCogstate Inc.PTY2024-08-24
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
G527GTDHIPALPRO01V1010HiPAL ProGT DIAGNOSTICS (UK) LIMITEDPTY2023-07-28
00860007318757Cognition Snapshot+ 2.2.0Qr8 Health IncPTY2023-05-22
00860009693401Speech Vitals - CognitionAural Analytics, Inc.PTY2022-12-15
00196852685837Speech Vitals - CognitionAural Analytics, Inc.PTY2022-11-07
G134NCCPL1NeuroCatch EEG CapNeuroCatch IncPTY2022-09-30