BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

    Reg #: 3005860720 · FEI: 3005860720 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    51
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
    Registration Number
    3005860720
    FEI Number
    3005860720
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9900 Innovation Drive
    City
    Wauwatosa
    State
    WI
    ZIP
    53226
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202132
    PMA Number
    P110006

    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Breast Ultrasound PAA
    System, Image Processing, Radiological LLZ

    Proprietary Names

    12S-RS L8-18i-RS L12n-RS 9L-RS L4-20t-RS Venue 12L-RS E8C-RS 6S-RS 3Sc-RS ML6-15-RS 8C-RS L4-12t-RS 6Tc-RS C1-5-RS L10-22-RS Venue Trident Invenia ABUS Workstation Invenia ABUS Invenia ABUS Scan Station Invenia ABUS Review Software ABUS Single-Use Stabilization Membrane - non Sterile Invenia ABUS 2 Invenia ABUS Prime Invenia ABUS Premium Venue Fit Venue Go L8-18i-D P6D LOGIQ E10 C1-6VN-D C3-10-D RIC5-9-D C1-6-D M5Sc-D 6S-D IC5-9-D L2-9VN-D ML6-15-D L2-9-D BE9CS-D RAB6-D P2D C2-9VN-D C2-9-D M5Sc-RS L4-20t-D ML4-20VN-D L3-12-D ML4-20-D Invenia ABUS Viewer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device