BEUDAMED
    FDA Registration Active 🇺🇸 United States

    United Imaging Healthcare North America, Inc

    Reg #: 3011950073 · FEI: 3011950073 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    United Imaging Healthcare North America, Inc
    Registration Number
    3011950073
    FEI Number
    3011950073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9230 Kirby Drive, Suite 600
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251167

    Owner / Operator

    Firm Name
    United Imaging Healthcare North America, Inc
    Operator Number
    10059541
    Address
    9230 Kirby Drive, Suite 600
    City
    Houston
    State
    TX
    Postal Code
    77054
    Country
    US
    Correspondent
    Hongdi LI

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, Nuclear Magnetic Resonance Imaging LNH
    Coil, Magnetic Resonance, Specialty MOS
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO
    System, X-Ray, Mobile IZL
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Automated Radiological Image Processing Software QIH
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    uPMR 790 uEXPLORER

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198