BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMSure 3D

    Reg #: 2184007 · FEI: 1000115748 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STANDARD IMAGING, INC.
    Registration Number
    2184007
    FEI Number
    1000115748
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3120 DEMING WAY
    City
    MIDDLETON
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180595

    Owner / Operator

    Firm Name
    STANDARD IMAGING, INC.
    Operator Number
    9003193
    Address
    3120 DEMING WAY, --
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Ellen M Young

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    IMSure 3D

    Establishment Types

    Repack or Relabel Medical Device