BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Healthcare Manufacturing LLC

    Reg #: 3015329423 · FEI: 3015329423 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    64
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GE Healthcare Manufacturing LLC
    Registration Number
    3015329423
    FEI Number
    3015329423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3280 General Williams W. Dr.
    City
    Florence
    State
    SC
    ZIP
    29506
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183231

    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

    SIGNA Premier Sonic DL SIGNA Artist AIR Recon DL SIGNA Architect 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 Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 SIGNA PET/MR SIGNA Sprint 1.5T AIR Posterior Array Discovery MR450 Optima MR450w 1.5T Discovery MR750 3T Discovery MR450 1.5T Discovery MR750w 3T 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 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 Sprint Select Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w 3T HNU 3T LAA 3T PET/MR CMA 3T UAA SIGNA Hero SIGNA Champion TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA GE 1.5T SIGNA HDE MR SYSTEM SIGNA Bolt 3T AIR PA XL SIGNA Artist Evo

    Establishment Types

    Manufacture Medical Device