BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Discovery XR656 HD with VolumeRad

    Reg #: 3013679558 · FEI: 3013679558 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Repair Operations Center
    Registration Number
    3013679558
    FEI Number
    3013679558
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    120 Opus Drive
    City
    Oak Creek
    State
    WI
    ZIP
    53154
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191699

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

    Proprietary Names

    Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Discovery XR656 HD Optima XR646 HD Discovery XR656 HD Upgrade Optima XR646 HD Upgrade

    Establishment Types

    Remanufacture Medical Device