BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Definium 8000

    Reg #: 2126677 · FEI: 2126677 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS, LLC
    Registration Number
    2126677
    FEI Number
    2126677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 N GRANDVIEW BLVD.
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051967

    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

    Products

    Device Name Product Code
    System, X-Ray, Tomographic IZF
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR

    Proprietary Names

    Definium 8000 Discovery XR650 Discovery XR656 Revolution XR/d Optima XR640

    Establishment Types

    Manufacture Medical Device