BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGNA Voyager Quantum

    Reg #: 3005326970 · FEI: 3005326970 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GE Healthcare Manufacturing LLC
    Registration Number
    3005326970
    FEI Number
    3005326970
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3001 W RADIO DR
    City
    FLORENCE
    State
    SC
    ZIP
    29501
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192426

    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
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    SIGNA Voyager Quantum 1.5T TDI Head Neck Array 1.5T TDI Posterior Array SIGNA Voyager 1.5T Anterior Array Signa Voyager Premier Edition

    Establishment Types

    Manufacture Medical Device