FDA.reportPublic FDA data

CNS Vital Signs VSC

Primary DI
00860013886127
Brand
CNS Vital Signs VSC
Company
CNS Vital Signs, LLC
Model
1.0
Device description
CNS Vital Signs cognitive testing installed locally on iOS platform. A set of Cognitive tests and clinical questionaires that can be administered in the office. Requires an internet connection.
Published
2025-09-01
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
00860013886127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013886127008600138861278600138861270860013886127

GMDN Terms#

Term, Definition table
TermDefinition
Psychological assessment softwareA screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153552802
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013886103CNS Vital Signs Web2.0.62025-07-07
00860013886110CNS Vital Signs Local4.0.1072025-07-07
00860013886134CNS Vital Signs Cognitrax1.1.42025-07-07

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
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
G676NEUROFLEX0NeuroFlexSaccade Analytiques IncPTY2025-04-29
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