BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AISight Dx

    Reg #: 3020687180 · FEI: 3020687180 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PATHAI
    Registration Number
    3020687180
    FEI Number
    3020687180
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1325 Boylston Street Suite 10000
    City
    Boston
    State
    MA
    ZIP
    02215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243391

    Owner / Operator

    Firm Name
    PathAI
    Operator Number
    10085829
    Address
    1325 Boylston Street Suite 10000
    City
    Boston
    State
    MA
    Postal Code
    02215
    Country
    US
    Correspondent
    Paul Gerrard

    Products

    Device Name Product Code
    Digital Pathology Image Viewing And Management Software QKQ

    Proprietary Names

    AISight Dx

    Establishment Types

    Manufacture Medical Device