BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE MEDICAL SYSTEMS, LLC

    Reg #: 2126677 · FEI: 2126677 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    206
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS, LLC
    Registration Number
    2126677
    FEI Number
    2126677
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3000 N GRANDVIEW BLVD.
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173602

    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
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Tomographic IZF
    System, X-Ray, Stationary KPR
    Instrument, Quality-Assurance, Radiologic LHO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    Radiological Image Processing Software For Radiation Therapy QKB
    Phantom, Anthropomorphic, Radiographic IXG
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS
    Collimator, Automatic, Radiographic IZW
    System, Nuclear Magnetic Resonance Imaging LNH
    Radiological Computer-Assisted Prioritization Software For Lesions QFM
    Test-Pattern, Radiographic IXF

    Proprietary Names

    Optima XR240amx Max Elite Omni Legend Max Apollo Discovery VCT-RX Discovery VCT Discovery RX VCT Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 Optima CT660sPro Optima CT660 Optima CT660s Optima CT660Pro Console Generation Upgrade CortexID Suite IQST assembly Quality Care Suite 2 GSI Viewer GSI Volume Viewer Discovery CT750 HD Operator Console for BrightSpeed Elite_BrightSpeed Elite Select Optima CT540 Precision 500D LightSpeed VCT LightSpeed VCT XTe Prestige VH Prestige SI Prestige II Prestige Remote R&F System Definium 5000 Low Dose CT Lung Cancer Screening Option for Qualified GE CT Systems Precision DL Photonova Spectra Select Photonova Spectra P500D Revolution CT Revolution CT ES Revolution Apex Revolution CT with Quantix Upgrade Revolution CT with Apex Edition MaxFOV 2 LightSpeed VCT Select LightSpeed VCT standard LightSpeed VCT XT LightSpeed Pro32 Critical Care Suite with Enteric Tube Positioning AI Algorithm CRC Customer Remote Console Remote Console Digital Expert Access AS Auto Segmentation Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Critical Care Suite 2 Discovery RT Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT SmartView 3D Option GE Veo Reconstruction Option Veo Collimator Collimator X-Ray Brivo XR285amx Optima XR220amx Optima XR200amx Enhanced Extream Injector Option Extream Injector Option ASiR-V Discovery IQ Discovery IQ Clarity RT Refresh Package SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT Discovery MI Columbia Discovery MI Discovery Max Discovery MI Gen2 Discovery Max+ Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660J Revolution EVO 33 kW/48 kW Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade SnapShot Freeze SnapShot Freeze 2 SSF2 SSF CARDIOVASCULAR PHANTOM Disocvery PET/CT 610 Clarity Discovery PET/CT 690 Discovery PET/CT 600 Optima 560 / Discovery 690 Elite Discovery PET/CT 610 Discovery PET/CT 710 Optima PET/CT 560 Optima PET/CT 560FX Deep Learning Image Reconstruction (DLIR) TrueFidelity PET Digital Gating MotionFree Critical Care Suite 2.1 Discovery CT Revolution Frontier Revolution Frontier ES Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Revolution CT ES with Apex edition Revolution Apex Plus Max Apollo + Max Elite + Revolution Maxima Revolution Ace Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Volume Viewer Reporting Tool Volume Viewer 4 Preprocessing Enabler PROView Volume Viewer MR Volume Viewer 2 Volume Viewer Innova Volume Viewer PET OncoQuant Volume Viewer Apps Volume Viewer 5 Autolaunch Volume Viewer 3.1 Volume Illumination Volume Viewer Innova 3DStent Volume Viewer Innova Enhanced Head Auto Views HAV AMX Navigate AMX Navigate UPGRADE Spectral Bone Marrow SBM GSI MSI GSI Materials GSI Gout GSI Viewer with VUE Option Spectral Color Overlay SCO True Definitional DL Revolution UPG 5 Revolution Ascend ES Revolution Ascend EX Revolution Ascend Revolution Ascend EL Revolution Ascend Plus Revolution Ascend Elite Revolution Ascend Select Revolution Vibe Discovery MI Gen 2 Discovery Max Pro Discovery Future Discovery Power Revolution UPG 3 ECG-less Cardiac Critical Care Suite Deep Learning Image Reconstruction Discovery PET/CT 710-64 Discovery PET/CT 710 Clarity Edition Discovery MI Digital Ready Discovery PET/CT 710 Clarity Coil QA Phantom Knee/Foot Phantoms Knee Coil Phantom Image Slice Phantom T/L Phantom Foot SNR Phantom CT Phantom Headset PHANTOM Auto Positioning Deep Learning Image Reconstruction for Gemstone Spectral Imaging True Enhance DL Revolution Apex Select Revolution CT with Apex edition Revolution Apex Select with Elite Edition Revolution Apex Select with Plus Edition Revolution CT Power Revolution Apex Elite

    Establishment Types

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