BEUDAMED
    FDA Registration Active 🇫🇷 France

    SONIO

    Reg #: 3029937167 · FEI: 3029937167 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    SONIO
    Registration Number
    3029937167
    FEI Number
    3029937167
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    147 rue d'Aboukir
    City
    Paris
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K243614

    Owner / Operator

    Firm Name
    Sonio
    Operator Number
    10088709
    Address
    147 rue d'Aboukir
    City
    Paris
    State
    FR-75
    Postal Code
    75002
    Country
    FR
    Correspondent
    Florian Akpakpa

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Sonio Suspect Sonio Detect Sonio Detect v2 Basic Image Processing

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device