FDA Product Code PKQ: Computerized Cognitive Assessment Aid
The Computerized Cognitive Assessment Aid Provides Clinicians In A Healthcare Setting With Objective Measurements Of Cognitive Function As A Screening Aid In The Assessment Of Adults 55 Years Of Age And Older. This Is Done For The Purpose Of Identifying A Potential Decline In Cognitive Function Relative To Baseline Test Performance Of Other Age-normal Adults, Referring Those Adults For Further Testing Where Warranted, And Monitoring Changes In Cognitive Function Over Time
Leading manufacturers include Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd., Cerebral Assessment Systems, Inc. and Vista Lifesciences, Inc..
3
Total
2
Cleared
395d
Avg days
2015
Since
FDA 510(k) Cleared Computerized Cognitive Assessment Aid Devices (Product Code PKQ)
3 devices
Cleared
Jan 13, 2017
Cantab Mobile
Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
Neurology
246d
Cleared
Aug 28, 2015
ANAM Test System: Military Battery
Vista Lifesciences, Inc.
Neurology
217d
Not Cleared
Jun 05, 2015
COGNIVUE
Cerebral Assessment Systems, Inc.
Neurology
723d