BEUDAMED
    FDA Registration Active 🇺🇸 United States

    1.5T Signa HDxt Mobile

    Reg #: 3015329423 · FEI: 3015329423 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE Healthcare Manufacturing LLC
    Registration Number
    3015329423
    FEI Number
    3015329423
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3280 General Williams W. Dr.
    City
    Florence
    State
    SC
    ZIP
    29506
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121676

    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

    Proprietary Names

    1.5T Signa HDxt Mobile 3T SIGNA HDxt Mobile 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 1.5T SIGNA HDXt SIGNA VIBRANT 3T SIGNA HDXt

    Establishment Types

    Manufacture Medical Device