BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

    Reg #: 3032008018 · FEI: 3032008018 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    70
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
    Registration Number
    3032008018
    FEI Number
    3032008018
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3200 N Grandview Blvd
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240206
    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 Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH
    Image Acquisition And/Or Optimization Guided By Artificial Intelligence QJU
    Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan QVD
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    Automated Breast Ultrasound PAA
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Venue Sprint IC5-9-D LOGIQ E10 RIC5-9-D C2-9-D L2-9-D ML6-15-D L8-18i-D C2-9VN-D 12S-D BE9CS-D P6D C1-6VN-D L3-12-D RAB6-D C3-10-D L2-9VN-D L4-20t-D M5Sc-D C1-6-D ML4-20-D P2D ML4-20VN-D 6S-D 6Tc-RS L10-22-RS 12S-RS L8-18i-RS L4-20t-RS Venue Go C2-9-RS 6S-RS E8C-RS M5Sc-RS Venue L12n-RS ML6-15-RS 12L-RS L4-12t-RS 3Sc-RS 8C-RS C1-5-RS 9L-RS Venue Fit Caption Guidance RAB2-5-D LOGIQ E9 M6C-D RSP6-16-D 3CRF RNA5-9-D 9L-D RAB4-8-D 11L-D C1-5-D LOGIQ E9 XDClear 2 S4-10-D Caption Interpretation PCCP Automated Aortic Stenosis Software 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 Caption Guidance PCCP Invenia ABUS Viewer Caption Interpretation

    Establishment Types

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