BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iScan Coreo Scanner

    Reg #: 2028492 · FEI: 1000125183 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    VENTANA MEDICAL SYSTEMS, INC.
    Registration Number
    2028492
    FEI Number
    1000125183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1910 EAST INNOVATION PARK DR.
    City
    Tucson
    State
    AZ
    ZIP
    85755
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140465

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    Products

    Device Name Product Code
    Automated Digital Image Manual Interpretation Microscope OEO
    Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity NQN
    Microscope, Automated, Image Analysis, Operator Intervention NOT

    Proprietary Names

    iScan Coreo Scanner

    Establishment Types

    Manufacture Medical Device