BEUDAMED
    FDA Registration Active 🇺🇸 United States

    1.5T HD Breast Array

    Reg #: 1529041 · FEI: 3005214683 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE Healthcare Coils
    Registration Number
    1529041
    FEI Number
    3005214683
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1515 DANNER DR
    City
    AURORA
    State
    OH
    ZIP
    44202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041695

    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, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    1.5T HD Breast Array liberty 9000 8-ch breast coil with disposable biopsy plate 1.5T 8Ch GEM Breast Coil Lateral Large Grid Biopsy Plate Medial Large Grid Breast Biopsy Plate 1.5T HD Flat GEM Table Breast Array

    Establishment Types

    Manufacture Medical Device