BEUDAMED
    FDA Registration Active 🇫🇷 France

    THERAPIXEL

    Reg #: 3016819165 · FEI: 3016819165 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    THERAPIXEL
    Registration Number
    3016819165
    FEI Number
    3016819165
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    455 Promenade des Anglais
    City
    Nice Alpes-Maritimes
    Country
    FR

    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

    US Agent

    Business Name
    VP, Digital Health, AI and Radiology
    Contact Name
    Alex Cadotte
    Address
    803 7th St Nw
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    347 3024549

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198