BEUDAMED
    FDA Registration Active 🇨🇳 China

    GE Healthcare (China) Co., Ltd.

    Reg #: 3008284470 · FEI: 3008284470 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    269
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    GE Healthcare (China) Co., Ltd.
    Registration Number
    3008284470
    FEI Number
    3008284470
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K051967

    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Tomographic IZF
    System, X-Ray, Stationary KPR
    Table, Radiographic, Non-Tilting, Powered IZZ
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, X-Ray, Tomography, Computed JAK
    Table, Radiographic, Tilting IXR
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Collimator, Automatic, Radiographic IZW
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Table, Radiologic KXJ
    Support, Patient Position CCX
    Tube Mount, X-Ray, Diagnostic IYB
    Instrument, Quality-Assurance, Radiologic LHO
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Automated Radiological Image Processing Software QIH
    System, X-Ray, Mobile IZL

    Proprietary Names

    Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 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 SIGNA Sprint 1.5T AIR Posterior Array Revolution Ascend Sliding 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 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Console Generation Upgrade Optima XR646 HD Optima XR646 HD Upgrade SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum 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 Revolution Maxima Revolution Ace Definium Tempo Select TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA Signa Voyager Premier Edition Table (Model: GCTBL-C44) SIGNA Prime Elite Auto Positioning Brivo XR385 Revolution ACT SIGNA Sprint Select Discovery XR656 with VolumeRAD MR Vectra Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Discovery XR656 HD Discovery XR656 HD Upgrade 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 5 3DXR Discovery IGS 7 OR Discovery IGS 7 Innova IGS 6 INNOVA IGS 540 INNOVA IGS 530 INNOVA IGS 520 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 SIGNA Champion Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator IGS WF BP Cardiac X-ray Analysis Innova IGS 3 IGS WF SP Allia IGS 3 Allia IGS 7 Allia IGS 7 OR Allia IGS 5 Optima IGS Mega Optima IGS Ultra Discovery CT Revolution Frontier Revolution Frontier ES Discovery CT750 HD Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Definium 5000 OEC One OEC One CFD Definium Pace Select ET LightSpeed VCT Select LightSpeed VCT LightSpeed Pro32 RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT OEC Elite MiniView OEC One ASD Revolution Vibe 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table SIGNA Victor Definium Pace Select SIGNA Prime LightSpeed VCT XTe REPRESSING BELT-ROHS REPRESSING BELT-Standard table Compression Band (Model: 5794807) Repression Belt (B2100BLT) 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) IQST assembly Quality Care Suite 2 Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT SIGNA Artist Evo SIGNA Artist LightSpeed VCT standard LightSpeed VCT XT Optima Advance Revolution Advance Revolution Eagle Optima CT520 Proteus XR/a GE 8CH Foot Ankle Coil Operator Console for BrightSpeed Elite_BrightSpeed Elite Select Optima CT540 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 SmartView 3D Option Optima XR646 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) MaxFOV 2 SIGNA Hero Flex Body Coil FlashPad Wireless DR Imaging Option (WDR1) 1.5T SPLIT HEAD COIL GE 1.5T SIGNA HDE MR SYSTEM Collimator Collimator X-Ray Brivo XR285amx Optima XR220amx Optima XR200amx SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility