BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    icometrix

    Reg #: 3013427569 · FEI: 3013427569 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    icometrix
    Registration Number
    3013427569
    FEI Number
    3013427569
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kolonel Begaultlaan 1b / 12
    City
    Leuven Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K181939

    Owner / Operator

    Firm Name
    icometrix
    Operator Number
    10052535
    Address
    Kolonel Begaultlaan 1b / 12
    City
    Leuven
    State
    Vlaams Brabant
    Postal Code
    3012
    Country
    BE
    Correspondent
    Dirk Smeets

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS
    Reminder, Medication NXQ

    Proprietary Names

    Concurrent supervision portal icobrain ct icobrain mr icobrain aria icompanion icobrain ctp

    Establishment Types

    Manufacture Medical Device