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510(k) Data Aggregation
K Number
K141865Device Name
DANA
Manufacturer
ANTHROTRONIX, INC
Date Cleared
2014-10-15
(97 days)
Product Code
LQD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ANTHROTRONIX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g. fatigue and stress).
DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.
Device Description
DANA is a mobile application indicated to provide clinicians with objective measurements of reaction time (speed and accuracy) and standardized health assessments to aid in the assessment of an individual's medical or psychological state. DANA results should be interpreted only by qualified professionals.
DANA was developed on a mobile platform to improve the access and availability of reaction time tests and standardized health assessments through (1) custom configuration of the system by clinicians based on their need and discretion; and (2) allowing for objective health assessments both in-clinic and out-of-clinic settings.
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