BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iMRX System

    Reg #: 3010326005 · FEI: 3010326005 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMRIS Imaging, Inc.
    Registration Number
    3010326005
    FEI Number
    3010326005
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1230 Chaska Creek Way Suite 100
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101813

    Owner / Operator

    Firm Name
    IMRIS Imaging, Inc.
    Operator Number
    10050332
    Address
    1230 Chaska Creek Way, Suite 100
    City
    Chaska
    State
    MN
    Postal Code
    55318
    Country
    US
    Correspondent
    Sanjay Shah

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    iMRX System

    Establishment Types

    Manufacture Medical Device