BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OPTIMA CT 580

    Reg #: 9612283 · FEI: 3002808529 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE Healthcare Japan Corporation
    Registration Number
    9612283
    FEI Number
    3002808529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7-127, Asahigaoka 4-chome
    City
    HINO-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K132410

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    OPTIMA CT 580 OPTIMA CT 580 W DISCOVERY CT 590 RT OPTIMA CT 580 RT Discovery RT SmartMAR Optima RT Revolution RT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility