BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    GE VINGMED ULTRASOUND A/S

    Reg #: 9610482 · FEI: 3002808457 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    184
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    GE VINGMED ULTRASOUND A/S
    Registration Number
    9610482
    FEI Number
    3002808457
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    STRANDPROMENADEN 45
    City
    HORTEN Vestfold
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K152195

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

    Proprietary Names

    9L-D RAB6-D C2-9-D C1-5-D C1-6-D ML6-15-D IC5-9-D LOGIQ S8 P6D L8-18i-D P2D L3-12-D RIC5-9-D 6S-D 6Tc-RS BE9CS-D RSP6-16-D C3-10-D 11L-D Voluson E6 Voluson E8 eM6C G2 L2-9-D RM7C C4-8-D Voluson E10 RM6C RAB2-5-D eM6C G3 RNA5-9-D RIC6-12-D eM6C IC9-D M5Sc-D C2-9VN-D L2-9VN-D C1-6VN-D LOGIQ E10s 6S-RS E8Cs-RS (only for Vivid T9) 4C-RS 3Sc-RS 9T-RS E8C-RS 12L-RS L8-18i-RS 12S-RS L6-12-RS Vivid T8 9L-RS C1-5-RS (only for Vivid T9) Vivid T9 8C-RS Vscan Extend G3S, deep scanning transducer G8L, shallow scanning transducer Vscan Extend dual probe dual probe L4-12t-RS ML6-15-RS M5Sc-RS Venue L4-20t-RS L12n-RS L10-22-RS C1-5-RS C2-9-RS Vivid iq 6VT-D 10T-D E8Cs-RS 4Vc-D Vivid S70N Vivid S60N 12S-D Vivid S70N Dimension Vscan Air Vscan Air SL Vscan Air CL EchoPAC Connect EchoPAC Suite EchoPAC Plug-in EchoPAC EchoPAC Software Only Vivid E90 iC5-9-D 9T Vivid E95 4V-D 8C Vivid E80 6Vc-D G3S, Deep Scanning Transducer G8L, Shallow Scanning Transducer LOGIQ Totus L6-24-D L4-20t-D LOGIQ E10 ML4-20VN-D ML4-20-D Venue Trident Venue Fit Venue Go ML6-15 BE9CS LOGIQ S7 Expert RAB4-8-D Voluson E series BT15 Voluson E series Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Vscan with Dual Probe Vivid Pioneer 9VT-D 6Sc-D 10-D RAB2-6-RS LOGIQ P9 M5sc-RS L3-12-RS LOGIQ P10 E8CS-RS BE9CS-RS LOGIQ P8 IC9-RS RIC5-9A-RS E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG LOGIQ e Versana Premier LOGIQ F Versana Premier Lotus LK760-RS Venue Sprint LOGIQ P7 Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L PA6-8-D RAM3-8 Probe Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG EchoPac 4D ICE catheter Vivid T8 T9 v206 to v208 SW only UPG P6D-RS 7S-RS 10S-RS 8L-RS 6Tc Vivid S70 Vivid S60 LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W LOGIQ Fortis LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade LOGIQ E10s R2R3 to R4 HW Upgrade W LOGIQ e NextGen NextGen LOGIQ e LOGIQ E9 M6C-D 3CRF LOGIQ E9 XDClear 2 S4-10-D LOGIQ E10s R2 to R3 UPG LOGIQ S20 LOGIQ S20 Express LOGIQ Vita Power LOGIQ Vita Express LOGIQ S20 Plus LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power LOGIQ Vita LOGIQ Vita Pro

    Establishment Types

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