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

Primary DI
00860334002121
Brand
ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports
Company
VISTA PARTNERS, LLC
Model
4.5.0.7
Device description
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.
Published
2023-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POMComputerized Cognitive Assessment Aid For Concussion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POMComputerized Cognitive Assessment Aid For ConcussionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201376000ANAM Test SystemVista Lifesciences, Inc.2021-03-25POM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860334002121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860334002121008603340021218603340021210860334002121

GMDN Terms#

Term, Definition table
TermDefinition
Psychological assessment softwareA screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-733-8804support@vistalifesciences.com

Regulatory Flags#

DUNS number
191819023
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860334002138ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports4.5.0.82025-11-24
00860334002114ANAM Test System4.52019-11-26
00860334002107ANAM Test System: Military Battery4.32018-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00868168000306SwayHEALTHY ROSTER LLCPOM2026-04-13
00860334002138ANAM Test System: Military, Military Expanded, Core, Core Expanded, and SportsVISTA PARTNERS, LLCPOM2025-11-24
00864127000356ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2021-03-05
00864127000349ImPACT Version 4IMPACT APPLICATIONS, INC.POM2021-02-27
00864127000325ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2017-07-31
00864127000301ImPACTIMPACT APPLICATIONS, INC.POM2016-11-29
00864127000318ImPACT PediatricIMPACT APPLICATIONS, INC.POM2016-11-29