BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Definium 8000

    Reg #: 3031503890 · FEI: 3031503890 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BLOCK IMAGING PARTS & SERVICE
    Registration Number
    3031503890
    FEI Number
    3031503890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1845 Cedar St.
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051967

    Owner / Operator

    Firm Name
    Block Imaging Parts & Service
    Operator Number
    10089799
    Address
    1845 Cedar St.
    City
    Holt
    State
    MI
    Postal Code
    48842
    Country
    US
    Correspondent
    Grace Lyon

    Products

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

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device