BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CT Cardiac Analysis

    Reg #: 2134213 · FEI: 3001654007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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
    K052632

    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

    CT Cardiac Analysis Vitrea LT Vitrea Neurovascular package VitreaWorkstation fX Vitrea Oncology package Vitrea Vitrea Enterprise Suite Vitrea fX Vitrea Cardiovascular package VitreaAdvanced CT Colon Analysis CT VScore General Vessel Probe CT Multi-Chamber Cardiac Functional Analysis VitreaWorkStation CT Cardiac Functional Analysis Vitrea Pediatric package VitreaAdvanced fX

    Establishment Types

    Manufacture Medical Device