BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Persyst ESI powered by Epilog

    DI: 05430000733038 · Model: v3 · Clouds of Care
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Persyst ESI powered by Epilog
    Primary DI
    05430000733038
    Version / Model
    v3
    Company Name
    Clouds of Care
    Labeler DUNS
    371252830
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-20
    Public Version
    1
    Public Version Date
    2026-04-28
    Public Version Status
    New
    Public Device Record Key
    c6c9fdc3-d6c0-4d53-9f1e-410883f065d3

    Device Description

    Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

    GMDN Terms

    Code Name
    67670 Electroencephalographic diagnosis-support software

    Identifiers

    Type ID
    Primary 05430000733038