FDA.reportPublic FDA data

DCTclock

Primary DI
B626100722
Brand
DCTclock
Company
DIGITAL COGNITION TECHNOLOGIES, 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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
047303734
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
B626100391DCTclock10039100392018-02-16
B626100931DCTclock10093100932018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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