DEVICE: ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports (00860334002121)
Device Identifier (DI) Information
ANAM Test System: Military, Military Expanded, Core, Core Expanded, and Sports
4.5.0.7
In Commercial Distribution
VISTA PARTNERS, LLC
4.5.0.7
In Commercial Distribution
VISTA PARTNERS, LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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58290 | Psychological assessment software |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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POM | Computerized Cognitive Assessment Aid For Concussion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K201376 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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Device Record Status
51a2d7cf-0665-4903-97b2-748c96553198
August 14, 2023
1
August 04, 2023
August 14, 2023
1
August 04, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-733-8804
support@vistalifesciences.com
support@vistalifesciences.com