BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genius AI Detection PRO Density

    Reg #: 3016759115 · FEI: 3016759115 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Therapixel Inc.
    Registration Number
    3016759115
    FEI Number
    3016759115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1700 W Irving Park Rd ST. 209A
    City
    Chicago
    State
    IL
    ZIP
    60613
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241561

    Owner / Operator

    Firm Name
    THERAPIXEL
    Operator Number
    10071453
    Address
    1 Impasse Reille
    City
    Paris
    State
    FR-75
    Postal Code
    75014
    Country
    FR
    Correspondent
    Pierre Fillard

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Genius AI Detection PRO Density MammoScreen BD

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198