BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    GE Vingmed Ultrasound AS

    Reg #: 3032807464 · FEI: 3032807464 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    GE Vingmed Ultrasound AS
    Registration Number
    3032807464
    FEI Number
    3032807464
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gaustadalleen 21
    City
    Oslo
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K251342

    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

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    EchoPAC Connect EchoPAC Suite EchoPAC Plug-in EchoPAC EchoPAC Software Only 6S-D 10T-D Vivid E90 M5Sc-D 12S-D 11L-D 6Tc-RS 9T-RS iC5-9-D 9L-D C2-9-D 9T Vivid E95 ML6-15-D 6VT-D C3-10-D P2D 4V-D P6D 8C Vivid E80 C1-6-D L8-18i-D 6Vc-D 4Vc-D Vivid Pioneer 9VT-D 6Sc-D 10-D Vivid S70N C1-5-D IC5-9-D Vivid S60N 3Sc-RS Vscan Extend G3S, deep scanning transducer G8L, shallow scanning transducer Vscan Extend dual probe dual probe Vscan with Dual Probe Vivid S70N Dimension Vscan Air CL Vscan Air Vscan Air SL 6Tc Vivid S70 Vivid S60 G3S, Deep Scanning Transducer G8L, Shallow Scanning Transducer EchoPac 4D ICE catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility