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    K Number
    K222101
    Device Name
    Prism
    Manufacturer
    GrayMatters Health Ltd.
    Date Cleared
    2023-03-17

    (242 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    GrayMatters Health Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prism is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback. The device is indicated as an adjunctive treatment of symptoms associated with posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.
    Device Description
    Prism is a software as medical device, to be prescribed for treatment of patients with PTSD by clinicians as adjunct to standard of care. Prism is a software device running on a laptop that uses EEG signal input from an EEG device (g.Nautilos PRO (K171669)). Prism therapy consists of 15, 30-minute sessions and optional periodic refresher sessions. During a session, the patient is connected to 8 or more EEG channels and views an interactive audio/visual interface.
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