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 Identify
| Device Type ID | 3786 |
| Device Name | Computerized Cognitive Assessment Aid |
| 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 Description | Computerized Cognitive Assessment Aid. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3786 |
| Device | Computerized Cognitive Assessment Aid |
| Product Code | PKQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Computerized Cognitive Assessment Aid. |
| CFR Regulation Number | 882.1470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VISTA LIFESCIENCES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |