ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports

GUDID 00860334002138

The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, 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 is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.

VISTA PARTNERS, LLC

Psychological assessment software
Primary Device ID00860334002138
NIH Device Record Keyf167c6f8-46e5-4715-918d-f3c0519cb267
Commercial Distribution StatusIn Commercial Distribution
Brand NameANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports
Version Model Number4.5.0.8
Company DUNS191819023
Company NameVISTA PARTNERS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com
Phone888-733-8804
Emailsupport@vistalifesciences.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860334002138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

POMComputerized Cognitive Assessment Aid For Concussion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

On-Brand Devices [ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports]

00860334002121The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries a
00860334002138The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries a
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