BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Focalyx Fusion

    Reg #: 3016567400 · FEI: 3016567400 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FOCALYX TECHNOLOGIES
    Registration Number
    3016567400
    FEI Number
    3016567400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2140 West 68th Street, Suite 200b
    City
    Hialeah
    State
    FL
    ZIP
    33016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170250

    Owner / Operator

    Firm Name
    Focalyx Technologies
    Operator Number
    10062693
    Address
    2140 West 68th Street, Suite 204
    City
    Hialeah
    State
    FL
    Postal Code
    33016
    Country
    US

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Focalyx Fusion Smartblate

    Establishment Types

    Manufacture Medical Device