BEUDAMED
    FDA Registration Active 🇫🇷 France

    GE MEDICAL SYSTEMS SCS

    Reg #: 9611343 · FEI: 1000284313 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    372
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS SCS
    Registration Number
    9611343
    FEI Number
    1000284313
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    283 RUE DE LA MINIERE
    City
    BUC
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K193281
    PMA Number
    P990066

    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
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Angiographic IZI
    Barrier, Control Panel, X-Ray, Movable IWX
    System, Tomography, Computed, Emission KPS
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, Nuclear Magnetic Resonance Imaging LNH
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Lung Computed Tomography System, Computer-Aided Detection OEB
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, Simulation, Radiation Therapy KPQ
    System, X-Ray, Mammographic IZH
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Digital Breast Tomosynthesis OTE

    Proprietary Names

    Hepatic VCAR Hepatic VCAR Gen2 Advantage 4D Innova 4100-IQ Innova 3100-IQ Innova 2121-IQ Innova 3131-IQ Innova 2100-IQ INNOVA IGS 620 Optima CL323i Integrated Innova - s5i system option INNOVA IGS 530 INNOVA IGS 630 Optima CL320i INNOVA IGS 520 INNOVA IGS 540 Thoracic VCAR GSI PP GSI Pulmonary Perfusion TVCAR Radiation Screen Radiation Screen Extension Radiation Screen for Control Station Liver Suite PET VCAR DEAUVILLE PET VCAR cvi42 cvi42_Mitral cvi42_cmr42 SnapShot Freeze SnapShot Freeze 2 SSF2 SSF Innova 3100 Seno Iris FlightPlan for Liver with Parenchyma Analysis option FlightPlan for EVAR MR VesselIQ Xpress MR Touch MR-Touch Option Innova 4100 Innova 2100 IQ Discovery IGS 740 Discovery IGS 7 3DXR Discovery IGS 7 OR CardiacVX CardiacVX Flow CardiacVX StarMap Stereo 3D Stereo 3D option for Vision Applications AdvantageALA Lung VCAR Senographe Pristina Pristina Via EVARVision TrackVision 2 Vision 2 HeartVision 2 CT Perfusion 4D Neuro CT Perfusion 4D Multi-Organ Send by mail FastStroke Dynamic CT Myocardial Perfusion CT Perfusion 4D CT Perfusion 4D Neuro Gen2 CardIQ Xpress Process CardIQ Xpress Reveal CardIQ Xpress 2 CardIQ Xpress Process 2 with Snapshot Freeze option CardIQ Fusion PET CardIQ Fusion SPECT AdvantageSim¿ MD GenIQ Senographe Essential Stereotaxy Senographe DS Stereotaxy Stereotix Senographic Stereo FlightPlan for Liver Dentascan MR Pasting MR pasting 1.1 Innova 2121 IQ Innova 3131 IQ Sample Imaging for Senographe Pristina SmartScore Smartscore 4 Dynamic Shuttle AutoBone Refresh AutoBone Xpress SenoBright HD Pristina Serena Bright Innova EPVision 2 Senographe 600T Senographe 500T CT Perfusion MULTI-ORGAN CT Perfusion 4 Neuro DMR+ Senographe DMR Mirada RTx AngioCard ReportCard 4 StarMap GE Delta Software Option for MRI Flow Analysis 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 VersaViewer DynamicIQ cmr42 TAVI Analysis TAVI VesselIQ Xpress TAVI Analysis Gen2 AVA Xpress VessellQ IXray Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade Senographe Pristina (Pristina Via) Pristina Serena Motion VUE Q.Freeze 2 Q.Freeze Pristina Serena 3D CardIQ Flow eContrast NEW Innova CT CortexID Suite SenoVision Advantage Paste Patient-Assisted Compression Self-Compression Pristina Dueta INNOVA 2121-IQ INNOVA 3131-IQ DISCOVERY IGS 730 INNOVA 4100-IQ INNOVA 2100-IQ Optima IGS 320 INNOVA 3100-IQ Optima IGS 330 Innova IGS 5 Innova IGS 6 Allia Moveo Spine Auto Views Mobile Senographe Essential Senographe Care Senographe Essential Senographe DS Senographe 2000D Allia IGS 3 Allia IGS 7 OR Allia IGS 7 Allia IGS 5 Bone VCAR BVCAR MAGiC MAGnetic resonance image Compilation FlightPlan for Embolization, with AI Segmentation option FlightPlan for Embolization AdvantageCTC Pro3D Advantage CTC Plus AdvantageCTC Pro3D EC AdvantageCTC Pro CardIQ Suite AW Remote Access AW 4.4 AW Volume Share 2 AW 4.3 AW Volume Share 4 advantage workstation 4.3 AW 4.5 SenoBright - CESM 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 CardEP INTERACT Discovery RT GSI Viewer GSI Volume Viewer Discovery CT750 HD IGS WF BP Cardiac X-ray Analysis Innova IGS 3 IGS WF SP Optima IGS Mega Optima IGS Ultra BreView AdvantageSim™ MD MR pelvic organ at risk segmentation Option eContrast PROView Automatic Segmentation PROView Premium View i Integrated Registration BrainWave Adv Visualization BrainWave Performance Brainwave PA Performance Brainwave PA Fusion Performance BrainWave Adv DTI Tracking BrainWave Fusion Perf BrainWave Struct Reporting BrainWave Post Acquisition (PA) BrainWave BrainWave Tract Generation Brainwave PA BrainWave Skull Stripping Brainwave Resting State Volume Viewer Volume Viewer Apps Dynamic VUE Innova IGS 520 Innova IGS 540 Innova IGS 530 GSI Viewer with GSI Fat Option GSI Fat AdvantageSim¿ MD with CT Atlas-based Contouring and Re-planning Options AdvantageSim MD AW VolumeShare 7 AngioViz AW 4.7 AW VolumeShare 5 with AngioViz GSI MSI GSI Materials GSI Gout GSI Viewer with VUE Option Spectral Color Overlay SCO Spectral Bone Marrow SBM Reporting Tool Volume Viewer 4 Preprocessing Enabler Volume Viewer MR Volume Viewer 2 Volume Viewer Innova Volume Viewer PET OncoQuant Volume Viewer 5 Autolaunch Volume Viewer 3.1 Volume Illumination Volume Viewer Innova 3DStent Volume Viewer Innova Enhanced Head Auto Views HAV Innova3DXR Brain View Body View READY View MAGiC DWI for AW READY View AD/RD READY View NRR READY View R2 Error CardIQ Function Xpress Seno Advantage 2.1 Seno Advantage 2.2 CADstream 5.2 AW Server 3.1 AW Server 3 AW Server 2 AW Server 3.2 AW Server Quantib Brain Quantib Brain 1.3 CleaRecon DL 3DStent Senographe 800T Senographe 700T CardIQ Physio Advantage 3D XR SenoClaire - GE Breast Tomosynthesis Senographe Pristina 3D Discovery IGS 730 INNOVA EPVISION INNOVA TRACKVISION INNOVA VISION INNOVA HEARTVISION

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)