BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Therapixel Inc.

    Reg #: 3016759115 · FEI: 3016759115 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Therapixel Inc.
    Registration Number
    3016759115
    FEI Number
    3016759115
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1700 W Irving Park Rd ST. 209A
    City
    Chicago
    State
    IL
    ZIP
    60613
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211541

    Owner / Operator

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

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ
    Automated Radiological Image Processing Software QIH
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    MammoScreen MammoScreen® MammoScreen® 4 Genius AI® Detection PRO MammoScreen 4 Genius AI Detection PRO Density MammoScreen BD MammoScreen 3 MammoScreen® 3 Genius AI Detection PRO Image Quality for Quality MammoScreen QC

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198