BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

    Reg #: 3002183074 · FEI: 3002183074 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    139
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
    Registration Number
    3002183074
    FEI Number
    3002183074
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14470 Bergen Blvd.
    City
    Noblesville
    State
    IN
    ZIP
    46060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253370

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

    Proprietary Names

    6S-D LOGIQ Totus C1-6VN-D ML6-15-D L6-24-D C1-6-D P2D L4-20t-D M5Sc-D C2-9-D 6Tc-RS P6D IC5-9-D RAB6-D L3-12-D C3-10-D RIC5-9-D E8Cs-RS ML6-15-RS C1-5-RS E8C-RS 4C-RS M5Sc-RS 6S-RS Vivid T8 T9 v204 v205 to v206 UPG SW only 9L-RS Vivid T8 T9 v204 v205 to v206 UPG L6-12-RS 12L-RS Vivid T9 Vivid T8 L8-18i-RS 3Sc-RS 8C-RS L4-20t-RS 12S-RS 9T-RS C2-9VN-D LOGIQ E10 L8-18i-D ML4-20VN-D L2-9-D BE9CS-D L2-9VN-D ML4-20-D L10-22-RS Venue Fit L4-12t-RS LOGIQ E10s LOGIQ Fortis LOGIQ E10s R2 to R3 UPG 11L-D IC9-D 9L-D C1-5-D RSP6-16-D eM6C G2 RM7C eM6C Voluson E10 RAB2-5-D RIC6-12-D Voluson E6 Voluson E8 RNA5-9-D RM6C LK760-RS Versana Active RAB2-6-RS Vivid S70N 6VT-D Vivid S60N 10T-D 12S-D LOGIQ e NextGen LOGIQ e NextGen LOGIQ e Vivid iq Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Venue Go C2-9-RS L12n-RS Venue 4Vc-D Voluson Expert 18 RIC10-D RAB7-D Voluson Expert 22 RIC12-D Voluson Expert 20 eM6C G3 RIC5-9A-RS Voluson P8 IC9-RS Voluson P6 IC9B-RS 9T Vivid E95 Vivid E80 4V-D 9VT-D 6Vc-D Vivid E90 8C iC5-9-D Venue Sprint LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W 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 Voluson S10 Voluson S8t Voluson S10 Expert Voluson S8 Voluson S6 Venue Trident BE9CS-RS M5sc-RS L3-12-RS LOGIQ P8 E8CS-RS LOGIQ P10 LOGIQ P9 Vivid T8 T9 v206 to v208 SW only UPG C4-8-D Vivid S70N Dimension E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG Voluson SWIFT+ RAB6-RS Voluson SWIFT Versana Premier

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device