Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K201376
    Device Name
    ANAM Test System
    Manufacturer
    Vista LifeSciences, Inc.
    Date Cleared
    2021-03-25

    (303 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vista LifeSciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment 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.
    Device Description
    The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance in populations, to aid in the assessment and management of concussion. ANAM measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker. The software is downloaded from the Vista LifeSciences website and is for use on Dell Inspiron 15 3000 Series or similar Windows PC model or Android Samsung Galaxy tablet or similar Android device. The hardware is not provided as part of the device but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner. Specific modules included in the ANAM Test System: - 1. Questionnaires - 1. Demographics - 2. Mood Scale - 3. Neurobehavioral Symptom Inventory (NSI) - 4. PTSD Checklist (PCL) - 5. Sleepiness Scale - 6. Symptoms Checklist - 7. TBI Questionnaire #### Performance Tests - 8. Code Substitution Learning - 9. Code Substitution Delayed - 10. Go/No-Go" - 11. Matching to Sample* - 12. Mathematical Processing - 13. Memory Search - 14. Procedural Reaction Time - 15. Simple Reaction Time* - 16. Spatial Processing* - *Available for tablet platform. The tests and questionnaires can be combined into custom batteries or users can choose from pre-configured standardized batteries. The standardized batteries include ANAM Core, ANAM Sports. ANAM Military, and ANAM Military-Expanded. These standardized batteries have fixed test settings and parameters to ensure standardized presentation and enable comparison to normative data.
    Ask a Question
    K Number
    K150154
    Device Name
    ANAM Test System: Military Battery
    Manufacturer
    Vista LifeSciences, Inc.
    Date Cleared
    2015-08-28

    (217 days)

    Product Code
    PKQ
    Regulation Number
    882.1470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vista LifeSciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
    Device Description
    ANAM Test System: Military Battery is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop is not provided as part of the device, but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.
    Ask a Question

    Page 1 of 1