BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Healthcare Manufacturing LLC

    Reg #: 3005326970 · FEI: 3005326970 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    71
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GE Healthcare Manufacturing LLC
    Registration Number
    3005326970
    FEI Number
    3005326970
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3001 W RADIO DR
    City
    FLORENCE
    State
    SC
    ZIP
    29501
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081916

    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
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO

    Proprietary Names

    GE Signa MR Oncology Package SIGNA Champion SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum AIR Recon DL Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w SIGNA 7T SIGNA PET/MR 3T HNU 3T LAA 3T PET/MR CMA 3T UAA 3T AA TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T SIGNA HDxt Mobile 3T SPLIT HEAD COIL 1.5T SPLIT HEAD COIL SIGNA VIBRANT 3T SIGNA HDXt 1.5T SIGNA HDXt 1.5T Signa HDxt Mobile SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 Signa Voyager Premier Edition Discovery MR750w 3T Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) SIGNA Premier SIGNA Architect SIGNA Hero GE 1.5T SIGNA HDE MR SYSTEM SIGNA Prime 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD GE SIGNA EXCITE MR SURGICAL OPTION SIGNA Bolt 3T AIR PA XL SIGNA Victor SIGNA Sprint Select SIGNA Sprint 1.5T AIR Posterior Array Optima MR450w 1.5T Discovery MR450 1.5T Discovery MR750 3T SIGNA Artist Sonic DL MR Radiation Oncology Options SIGNA Artist Evo Signa HDi 1.5T GE 3T Signa HDxt MR System Signa HDi GE 1.5T Signa HDx MR System GE 1.5T Signa HDxt MR System GE 3T Signa HDx MR System Signa Vibrant Discovery MR450

    Establishment Types

    Manufacture Medical Device