BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Voluson E8

    Reg #: 2032350 · FEI: 3003309342 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE PARALLEL DESIGN, INC.
    Registration Number
    2032350
    FEI Number
    3003309342
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4313 E COTTON CENTER BLVD STE 100
    City
    PHOENIX
    State
    AZ
    ZIP
    85040
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122327

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

    Proprietary Names

    Voluson E8 SP10-16-D 3S-D PA6-8-D AB2-7-D RM14L RSM5-14 RRE6-10-D Voluson E10 RRE5-10-D RAM3-8 Voluson E6 Voluson E8 Expert Probe

    Establishment Types

    Manufacture Medical Device