BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IC9-RS

    Reg #: 3002183074 · FEI: 3002183074 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
    Registration Number
    3002183074
    FEI Number
    3002183074
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14470 Bergen Blvd.
    City
    Noblesville
    State
    IN
    ZIP
    46060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213642

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    IC9-RS IC9B-RS Voluson S8t 3Sc-RS C1-5-RS 8C-RS Voluson S10 RIC5-9A-RS Voluson S6 9L-RS RAB2-6-RS Voluson S10 Expert 4C-RS ML6-15-RS 12L-RS 12S-RS Voluson S8 C2-9-RS

    Establishment Types

    Remanufacture Medical Device