Device typeCognitive assessment software: A 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.
FDA categoryComputerized Cognitive Assessment Aid For Concussion
Device ID00864127000356
MRI safetyLabeling does not contain MRI Safety Information