FDA.reportPublic FDA data

DCTclock

Primary DI
B626100720
Brand
DCTclock
Company
Linus Health, Inc.
Model
10072
Catalog number
10072
Device description
DCTclock Test Form - Clinical
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
B626100721PackageHIBCC25In Commercial Distribution
B626100722PackageHIBCC2In Commercial Distribution
B626100720PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Drawing-test cognitive function analysis deviceA device designed for professional assessment of a patient’s cognitive function by means of software-based analysis and interpretation of a drawing test (e.g., clock drawing test) performed by the patient. It consists of an electronic digital input device (e.g., pen with a built-in camera), and software; the results are typically combined with patient demographics to provide a summary report.

Contacts#

Phone, Email table
PhoneEmail
617-433-1777support@digitalcogtech.com

Regulatory Flags#

DUNS number
117137874
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B626200050Core Cognitive Evaluation20005200052024-06-05
B626200020Research Platform200022022-09-03
B626200010Core Cognitive Evaluation 20001200012022-06-28
B626100390DCTclock10039100392018-02-16
B626100930DCTclock10093100932018-02-16
B626100030DCTclock10003100032018-02-16
B626100040DCTclock10004100042018-02-16
B626100050DCTclock10005100052018-02-16
B626100060DCTclock10006100062018-02-16
B626100150DCTclock10015100152018-02-16
B626100410DCTclock10041100412018-02-16
B626100960DCTclock10096100962018-02-16
B62611100DCTclock111011102018-02-16

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
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