BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VitreaWorkstation fX

    Reg #: 2134213 · FEI: 3001654007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CANON MEDICAL INFORMATICS, INC.
    Registration Number
    2134213
    FEI Number
    3001654007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5850 Opus Parkway Suite 300
    City
    MINNETONKA
    State
    MN
    ZIP
    55343
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141302

    Owner / Operator

    Firm Name
    CANON MEDICAL INFORMATICS, INC.
    Operator Number
    9024582
    Address
    5850 OPUS PARKWAY, SUITE 300
    City
    Minnetonka
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Vincent J Swenson

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    VitreaWorkstation fX VitreaWorkStation Vitrea Cardiovascular package VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS VitreaAdvanced fX Vitrea, Vitrea fX Vitrea Enterprise Suite VitreaAdvanced

    Establishment Types

    Manufacture Medical Device