BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

    Reg #: 2183066 · FEI: 2183066 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    118
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
    Registration Number
    2183066
    FEI Number
    2183066
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3030 Ohmeda Drive
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252718

    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
    Densitometer, Bone KGI
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Collimator, Automatic, Radiographic IZW
    Assembly, Tube Housing, X-Ray, Diagnostic ITY

    Proprietary Names

    Lunar Astra Aria Aria X-Ray Bone Densitometer Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix GEHC DXA Bone Densitometers with enCORE version 18 Prodigy Primo Prodigy Pro Compact Prodigy Advance Lunar iDXA Prodigy Pro Prodigy Primo Compact Prodigy Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator GE Lunar DXA Bone Densitometers with enCORE version 16 iDXA GE Lunar DXA Bone Densitometers with enCORE version 17 Performix Plus LU43318ST LU8548STR Performix 40 Plus MAXIRAY 100 TH-M1 APOLLON Solarix 350 Brightspeed Performix HD 43318 45645 Performix Pulsar Performix VCT Plus Performix 40 LU45649ST LU45645STR Vamana Surgery MX100 FL MX135CT TH1.1 Maxiray MX100 FL Maxiray CT VCT MX200CT/Performix Ultra 5855555 LU45645 SB-80-200R Performix 160A LU8743STR Ergo MONOBLOCK Performix Pro VCT 100 LU45649 Maxiray MX100 RAD LU45649STR LU45645ST LU40782 Brivo OEC 2.2A X-ray Generator MX100 RAD LU8743ST Vamana RAD LU8548ST 40782 Performix HD Plus Artemis MX165 NP Quantix 160 Maxiray CT Ultra Performix HDw

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility