BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IQ-SYSTEM PACS

    Reg #: 3006165530 · FEI: 3006165530 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMAGE INFORMATION SYSTEMS EUROPE GmbH
    Registration Number
    3006165530
    FEI Number
    3006165530
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lange Strasse 16
    City
    ROSTOCK Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K062488

    Owner / Operator

    Firm Name
    IMAGE Information Systems Europe GmbH
    Operator Number
    9091611
    Address
    Lange Strasse 16
    City
    Rostock
    State
    Mecklenburg-Western Pomerania
    Postal Code
    18055
    Country
    DE

    US Agent

    Business Name
    Josh Baker Solutions
    Contact Name
    Josh Baker
    Address
    32565 B Golden Lantern #1048
    City
    Dana Point
    State
    CA
    ZIP
    92629
    Country
    US
    Email
    [email protected]
    Phone
    714 7888152

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    IQ-SYSTEM PACS

    Establishment Types

    Manufacture Medical Device