K150154 is an FDA 510(k) clearance for the ANAM Test System: Military Battery. This device is classified as a Computerized Cognitive Assessment Aid (Class II - Special Controls, product code PKQ).
Submitted by Vista Lifesciences, Inc. (Parker, US). The FDA issued a Cleared decision on August 28, 2015, 217 days after receiving the submission on January 23, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1470. 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.
| 510(k) Number | K150154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2015 |
| Decision Date | August 28, 2015 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PKQ - Computerized Cognitive Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1470 |
| 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 |