BEUDAMED
    FDA Registration Active 🇨🇳 China

    GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Reg #: 9613445 · FEI: 3002175190 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    280
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Registration Number
    9613445
    FEI Number
    3002175190
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    West Area of Building No.3, No.1 Yongchang North Road, Beijing Economic and Technological Development Area
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K171800

    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, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    System, Image Processing, Radiological LLZ
    Support, Patient Position CCX
    System, X-Ray, Tomography, Computed JAK
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL
    System, Tomography, Computed, Emission KPS
    Instrument, Quality-Assurance, Radiologic LHO
    Automated Radiological Image Processing Software QIH
    Densitometer, Bone KGI
    Collimator, Automatic, Radiographic IZW
    Holder, Radiographic Cassette, Wall-Mounted IXY
    System, X-Ray, Tomographic IZF
    Table, Radiographic, Non-Tilting, Powered IZZ
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Tilting IXR
    System, X-Ray, Angiographic IZI
    Bed, Scanning, Nuclear IYZ

    Proprietary Names

    OEC Elite MiniView 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 Xeleris 4 Processing and Review Workstation Xeleris 4 DR Processing and Review Workstation REPRESSING BELT-ROHS REPRESSING BELT-Standard table Compression Band (Model: 5794807) Repression Belt (B2100BLT) Revolution ACT TrueFidelity Deep Learning Image Reconstruction (DLIR) OEC One OEC One CFD OEC One ASD Definium Tempo Select Collimator Collimator X-Ray Brivo XR285amx Optima XR220amx Optima XR200amx Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade True Enhance DL Discovery RT Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT Max Apollo + Max Elite + Omni Legend Definium Pace Select ET IQST assembly Quality Care Suite 2 Lunar Astra Revolution Apex Select Revolution CT with Apex edition Revolution Apex Select with Elite Edition Revolution Apex Select with Plus Edition Revolution CT ES Revolution CT Power Revolution Apex Elite Revolution Apex Plus Revolution CT ES with Apex edition Enhanced Extream Injector Option Extream Injector Option Proteus XR/a Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Optima XR646 HD Optima XR646 HD Upgrade Discovery CT Revolution Frontier Revolution Frontier ES Discovery CT750 HD Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Wallstand (GCMWS-C5) WALL MOUNTED CASSETTE HOLDER Wallstand for X-Ray System Wallstand (Model: VMWS-1; VMWS-2) Wallstand (Model: GCEWS-C4) Wallstand (Model: GCWS-C3; GCWS-C5; GCWS-C6) Revolution Ascend ES Revolution Ascend EX Revolution Ascend Revolution Ascend EL Revolution Ascend Plus Revolution Ascend Elite Revolution Ascend Select Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660Pro Optima CT660sPro Optima CT660J Optima CT660 Revolution EVO 33 kW/48 kW Optima CT660s Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Revolution CT with Apex Edition Revolution CT Revolution Apex Brivo XR385 Brivo NM 615 Aurora Xeleris V Processing and Review System Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 NM 830 Discovery NM 630 True Definitional DL Revolution UPG 5 Discovery XR656 HD Discovery XR656 HD Upgrade NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE Definium Pace Select OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-7) Tubestand (Model: GCTS-C1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9) OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10) Tubestand (Model: GCTS-C11) OVERHEAD TUBE SUSPENSION (OTS for Discovery XR656 HD) (Model: 5135678-11) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8) Deep Learning Image Reconstruction for Gemstone Spectral Imaging SmartView 3D Option Discovery MI Gen 2 Discovery MI Gen2 Discovery Max Pro Discovery Future Discovery Power NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Table (Model: GCTBL-C44) Revolution Ascend Sliding Discovery XR656 with VolumeRAD RT Refresh Package SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT Operator Console for BrightSpeed Elite_BrightSpeed Elite Select Optima CT540 Discovery NM/CT 670 Pro Discovery NM/CT 670 ES NM/CT 870 DR Discovery NM/CT 670 Discovery 670 DR Revolution Vibe Precision DL Xeleris 3.1 Volumetrix MI XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION DaTQUANT Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Auto Positioning Innova IGS 5 IGS WF BP Discovery IGS 7 Cardiac X-ray Analysis Innova IGS 3 3DXR IGS WF SP Innova IGS 6 Discovery IGS 7 OR Allia IGS 3 Allia IGS 7 Allia IGS 7 OR Allia IGS 5 Optima IGS Mega Optima IGS Ultra OEC Brivo 715 Prime OEC Brivo 785 Essential OEC Brivo 865 Plus OEC Brivo Plus OEC Brivo Essential Brivo OEC 785 Brivo OEC 865 OEC Brivo Prime Brivo OEC 715 NM Patient Table Optima XR646 INNOVA IGS 620 INNOVA 2121-IQ INNOVA 3131-IQ DISCOVERY IGS 730 INNOVA 4100-IQ INNOVA 2100-IQ Optima IGS 320 Optima CL323i Optima CL320i INNOVA 3100-IQ INNOVA IGS 630 Optima IGS 330 INNOVA IGS 540 INNOVA IGS 530 INNOVA IGS 520 Optima Advance Revolution Advance Revolution Eagle Optima CT520 FlashPad Wireless DR Imaging Option (WDR1) Low Dose CT Lung Cancer Screening Option for Qualified GE CT Systems Max Elite Max Apollo MaxFOV 2

    Establishment Types

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