BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    GE Healthcare Austria GmbH & Co OG

    Reg #: 8020021 · FEI: 3004377820 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    202
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GE Healthcare Austria GmbH & Co OG
    Registration Number
    8020021
    FEI Number
    3004377820
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TIEFENBACH 15
    City
    ZIPF Oberosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K210438

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

    Proprietary Names

    L8-18i-RS E8Cs-RS 12S-RS Versana Premier 6S-RS LK760-RS E7C8L-RS 4C-RS L3-12-RS L6-12-RS C1-5-RS BE9CS-RS 12L-RS RIC5-9A-RS RAB2-6-RS E8C-RS 3Sc-RS 8C-RS 9L-RS 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L RAB6-D RIC10-D RSP6-16-D RM6C M5Sc-D C2-9-D RIC12-D 9L-D RIC5-9-D L8-18i-D RM7C C1-6-D Voluson Expert 22 Voluson Expert 20 ML6-15-D RIC6-12-D 12S-D IC5-9-D 6S-D 11L-D Voluson Expert 18 eM6C G3 eM6CG2 C1-5-D Voluson E6 IC9-D RAB2-5-D C4-8-D Voluson E series BT16 Voluson E8 Voluson E6 BT16 Voluson E10 BT16 eM6C Voluson E series Voluson E10 Voluson E8 BT16 LOGIQ V5 LOGIQ V5 Expert LOGIQ V3 LOGIQ S8 P6D P2D L3-12-D 6Tc-RS BE9CS-D C3-10-D Vscan Air Vscan Air SL Vscan Air CL LOGIQ E10 L2-9-D C2-9VN-D C1-6VN-D L2-9VN-D L4-20t-D ML4-20-D ML4-20VN-D Voluson P6 Voluson P8 IC9-RS Voluson Signature 20 Voluson Signature 18 LOGIQ E10s ML6-15-RS E8CS-RS LOGIQ P9 L10-22-RS L4-12t-RS LOGIQ P7 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 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 M5sc-RS LOGIQ P10 LOGIQ P8 LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG eM6C G2 RNA5-9-D L4-20t-RS C2-9-RS LOGIQ e Versana Essential Voluson S6 BT16 RAB6-RS Voluson S10 Voluson S series Voluson S8 BT16 Voluson S8 Voluson S6 Voluson S series BT16 Voluson S10 BT16 Voluson S8t Voluson S10 Expert IC9B-RS Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L PA6-8-D RAM3-8 Probe ML6-15 8C BE9CS LOGIQ S7 Expert RAB4-8-D 4Vc-D iC5-9-D Vivid Pioneer 9VT-D 6Sc-D 10-D 6VT-D 6Vc-D LOGIQ Totus Versana Active 4D View Voluson SWIFT+ Voluson SWIFT EchoPAC Connect EchoPAC Suite EchoPAC Plug-in EchoPAC EchoPAC Software Only LOGIQ F8 Expert LOGIQ F6 LOGIQ F8 L12n-RS LOGIQ F Versana Premier Lotus LOGIQ E9 M6C-D 3CRF LOGIQ E9 XDClear 2 S4-10-D M5Sc-RS Venue Versana Balance RAB4-8-RS Voluson i Voluson e RAB2-5-RS RIC5-9W-RS RNA5-9-RS Venue Fit LOGIQ P6 Pro LOGIQ P6 4D5C-L Venue Go Venue Sprint LOGIQ E10s R2 to R3 UPG Voluson Performance 18 Voluson Performance 16 RAB7-D L6-24-D Voluson E series BT15

    Establishment Types

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