# K201376: ANAM Test System

- Pathway: 510(k) (Traditional)
- Applicant: Vista Lifesciences, Inc.
- Decided: Mar 25, 2021 after 303 days
- Product code: POM (Computerized Cognitive Assessment Aid For Concussion)
- Device class: 2
- Regulation: 21 CFR 882.1471
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150037 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150037: ImPACT Computerized Neurocognitive Concussion Management Aid, Impact Applications, Inc. (2016) Summary page 4.

## Indications for use
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

Source page: https://510kreport.com/device/K201376
Methodology: https://510kreport.com/methodology