| Device |
computerized cognitive assessment aid |
| Regulation Description |
Computerized cognitive assessment aid. |
| Definition |
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 |
| Physical State |
Computer-administered battery of cognitive tests, computer keyboard, computer screen. |
| Technical Method |
Uses a battery of objective cognitive tests delivered by computer software to determine an individual's current level of cognitive functioning. |
| Target Area |
Brain |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | PKQ |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1470
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
