BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitrea Pediatric package

    Reg #: 2134213 · FEI: 3001654007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    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
    K040305

    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

    Vitrea Pediatric package Vitrea Oncology package Vitrea fX VitreaAdvanced fX Vitrea Enterprise Suite VitreaWorkStation Vitrea Cardiovascular package Toshiba International XA Angio fX package Vitrea XA Angio package VitreaAdvanced VitreaWorkstation fX Vitrea Neurovascular package Vitrea LT

    Establishment Types

    Manufacture Medical Device